Sulfate ( DrugBank: Sulfate )

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27 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
2	筋萎縮性側索硬化症	4
3	脊髄性筋萎縮症	1
6	パーキンソン病	1
11	重症筋無力症	2
13	多発性硬化症／視神経脊髄炎	6
26	HTLV-1関連脊髄症	2
28	全身性アミロイドーシス	1
34	神経線維腫症	19
36	表皮水疱症	5
46	悪性関節リウマチ	8
49	全身性エリテマトーデス	2
53	シェーグレン症候群	7
60	再生不良性貧血	1
64	血栓性血小板減少性紫斑病	1
66	IgA腎症	3
85	特発性間質性肺炎	2
86	肺動脈性肺高血圧症	1
96	クローン病	1
111	先天性ミオパチー	2
218	アルポート症候群	1
222	一次性ネフローゼ症候群	1
224	紫斑病性腎炎	1
226	間質性膀胱炎（ハンナ型）	4
265	脂肪萎縮症	3
296	胆道閉鎖症	1
297	アラジール症候群	1
299	嚢胞性線維症	35

2. 筋萎縮性側索硬化症

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臨床試験数 : 645 /  薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03883581 (ClinicalTrials.gov)	July 25, 2019	12/3/2019	Impact of Nuedexta on Bulbar Physiology and Function in ALS	Impact of Nuedexta on Bulbar Physiology and Function in ALS	Amyotrophic Lateral Sclerosis	Drug: dextromethorphan HBr and quinidine sulfate	University of Florida	Holy Cross Hospital, Florida;ALS Association	Completed	18 Years	90 Years	All	28	Phase 1/Phase 2	United States
2	EUCTR2018-000668-28-GB (EUCTR)	09/08/2018	25/06/2018	A study to assess safety and acceptability of a treatment in patients with ALS	A Phase II pilot safety and tolerability study of ILB in patients with Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS) - The ALS Study	Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ILB: 100mg/ml solution for injection and infusion INN or Proposed INN: Dextran Sodium Sulfur Salt 5, Mw 5 kDa. a type of Low Molecular Weight Dextran Sulfate (LMW-DS) Other descriptive name: ILB	University of Birmingham	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	15	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
3	EUCTR2017-005065-47-SE (EUCTR)	15/05/2018	19/03/2018	A single-center, open single-arm study where the safety, tolerability and efficacy of subcutaneously administered ILB will be evaluated in patients with Amyotrophic Lateral Sclerosis.	A single-centre, open single-arm study where the safety, tolerability and efficacy of subcutaneously administered ILB will be evaluated in patients with Amyotrophic Lateral Sclerosis	Amyotrophic Lateral Sclerosis (ALS);Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: ILB Product Code: ILB INN or Proposed INN: ILB Other descriptive name: DEXTRAN SULFATE SODIUM	TikoMed AB	NULL	Not Recruiting			Female: yes Male: yes	15	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Sweden
4	NCT00573443 (ClinicalTrials.gov)	December 2007	13/12/2007	Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS	A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)	Pseudobulbar Affect (PBA)	Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: Placebo	Avanir Pharmaceuticals	INC Research	Completed	18 Years	80 Years	All	326	Phase 3	United States;Argentina;Brazil

3. 脊髄性筋萎縮症

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臨床試験数 : 237 /  薬物数 : 123 - (DrugBank : 29) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 75

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	ChiCTR2000041208	2020-12-30	2020-12-22	A randomized, double-blind, placebo parallel controlled clinical trial on the efficacy and safety of salbutamol sulfate tablets in the treatment of children with spinal muscular atrophy	A randomized, double-blind, placebo parallel controlled clinical trial on the efficacy and safety of salbutamol sulfate tablets in the treatment of children with spinal muscular atrophy	spinal muscular atrophy	experimental group: salbutamol sulfate tablets ;control group:placebo;	The Children's Hospital, Zhejiang University School of Medicine	NULL	Recruiting	2	17	Both	experimental group:60;control group:30;	Phase 4	China

6. パーキンソン病

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臨床試験数 : 2,307 /  薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT01313845 (ClinicalTrials.gov)	February 2011	10/3/2011	Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease	Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's Disease	Parkinson's Disease	Drug: amantadine sulfate;Drug: 0.9% sodium chloride	Jee-Young Lee	Seoul National University Boramae Hospital;Samsung Medical Center;Seoul National University Bundang Hospital;Hanyang University	Completed	30 Years	79 Years	Both	46	Phase 4	Korea, Republic of

11. 重症筋無力症

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臨床試験数 : 332 /  薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-000895-40-DK (EUCTR)	28/03/2019	26/02/2019	Beta-agonist Efficacy and Tolerability as Adjuvant therapy in Myasthenia Gravis	Beta-agonist Efficacy and Tolerability as Adjuvant therapy in Myasthenia Gravis - BETA-MG	Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Salbutamol WZF 4 mg INN or Proposed INN: Salbutamol Other descriptive name: SALBUTAMOL SULFATE PH. EUR.	Aarhus University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 3	Denmark
2	ChiCTR1800017696	2016-07-01	2018-08-10	Effect of Magnesium Sulfate on Muscle Strength in Patients with Myasthenia Gravis	Effect of Magnesium Sulfate on Muscle Strength in Patients with Myasthenia Gravis	Myasthenia Gravis	Group A:Magnesium Sulfate;Group B:Normal saline;	The University of Hong Kong-Shenzhen Hospital	NULL	Recruiting	18	60	Both	Group A:30;Group B:30;		China

13. 多発性硬化症／視神経脊髄炎

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臨床試験数 : 3,340 /  薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2022-003170-23-FI (EUCTR)	20/12/2022	30/09/2022	Hydroxychloroquine in progressive MS	Prospective, randomized, double-blind, placebo-controlled, single-center comparative trial evaluating oral hydroxychloroquine 200 mg BID for reducing microglial activation in the brain of patients with progressive multiple sclerosis (MS)	Progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Oxiklorin Product Name: Oxiklorin INN or Proposed INN: Hydroxychloroquine sulfate	Varsinais-Suomen sairaanhoitopiirin kuntayhtymä	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	Finland
2	EUCTR2011-002178-22-GB (EUCTR)	27/04/2012	29/03/2012	A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis	A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis	Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A	Avanir Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 2	United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom
3	EUCTR2011-002178-22-PL (EUCTR)	20/03/2012	25/11/2011	A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis	A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis	Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 15.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A	Avanir Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 2	United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom
4	EUCTR2011-002178-22-CZ (EUCTR)	08/02/2012	02/11/2011	A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis	A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis	Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A	Avanir Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 2	United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom
5	NCT01615887 (ClinicalTrials.gov)	November 2009	23/3/2011	Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis	Effects of Lisdexamfetamine on Bradyphrenia in Multiple Sclerosis	Multiple Sclerosis	Drug: lisdexamfetamine sulfate;Drug: placebo	State University of New York at Buffalo	NULL	Completed	18 Years	55 Years	Both	63	Phase 2	United States
6	NCT00573443 (ClinicalTrials.gov)	December 2007	13/12/2007	Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS	A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)	Pseudobulbar Affect (PBA)	Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: Placebo	Avanir Pharmaceuticals	INC Research	Completed	18 Years	80 Years	All	326	Phase 3	United States;Argentina;Brazil

先頭へ

26. HTLV-1関連脊髄症

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臨床試験数 : 29 /  薬物数 : 47 - (DrugBank : 29) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 119

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04301076 (ClinicalTrials.gov)	June 15, 2020	6/3/2020	Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment (EPOCH) for Adult T-Cell Leukemia-Lymphoma (ATL)	A Phase 1 Study of Lenalidomide in Combination With EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL)	Acute Adult T-Cell Leukemia/Lymphoma;Adult T-Cell Leukemia/Lymphoma;Chronic Adult T-Cell Leukemia/Lymphoma;HTLV-1 Infection	Drug: Cyclophosphamide;Drug: Doxorubicin Hydrochloride;Drug: Etoposide;Drug: Lenalidomide;Drug: Prednisone;Drug: Vincristine Sulfate	National Cancer Institute (NCI)	NULL	Recruiting	18 Years	N/A	All	30	Phase 1	United States
2	NCT00041327 (ClinicalTrials.gov)	October 2002	8/7/2002	Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma	Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma	Lymphoma	Biological: filgrastim;Biological: recombinant interferon alfa;Drug: Etoposide;Drug: cyclophosphamide;Drug: doxorubicin hydrochloride;Drug: lamivudine;Drug: prednisone;Drug: vincristine sulfate;Drug: zidovudine	AIDS Malignancy Consortium	National Cancer Institute (NCI)	Completed	18 Years	120 Years	Both	19	Phase 2	United States

28. 全身性アミロイドーシス

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臨床試験数 : 267 /  薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2011-001787-22-IT (EUCTR)	02/05/2012	12/01/2012	Treatment with pomalidomide and dexamethasone for previously treated patients with AL amyloidosis.	An open-label, phase II study of Pomalidomide and Dexamethasone (PDex) for previously treated patients with AL amyloidosis - PDex	Previously treated AL amyloidosis MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: pomalidomide Product Code: CC-4047 INN or Proposed INN: Pomalidomide INN or Proposed INN: DEXAMETHASONE SODIUM SULFATE	OSPEDALE POLICLINICO S. MATTEO	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 2	Italy

34. 神経線維腫症

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臨床試験数 : 133 /  薬物数 : 186 - (DrugBank : 67) / 標的遺伝子数 : 79 - 標的パスウェイ数 : 190

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2020-005608-20-ES (EUCTR)	16/02/2022	19/10/2021	Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE)	A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE) - SPRINKLE	Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Not possible to specify	Product Name: Selumetinib granules in sprinkle capsules for opening 5 mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib granules in sprinkle capsules for opening 7.5 mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Trade Name: Koselugo 10mg Product Name: Selumetinib capsules 10mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Trade Name: Koselugo 25mg Product Name: Selumetinib capsules 25mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	38	Phase 1;Phase 2	United States;Spain;Russian Federation;Netherlands;Germany;Italy
2	EUCTR2020-005607-39-PL (EUCTR)	25/01/2022	14/09/2021	Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas	A Phase III, Multicentre, International Study with a Parallel, Randomised, Double blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants with NF1 who have Symptomatic, Inoperable Plexiforn Neurofibromas (KOMET) - KOMET	Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Selumetinib 10mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib 25mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	146	Phase 3	United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Brazil;Australia;Netherlands;Germany;China;Japan
3	EUCTR2020-005608-20-NL (EUCTR)	24/01/2022	21/10/2021	Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE)	A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE) - SPRINKLE	Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Not possible to specify	Product Name: Selumetinib granules in sprinkle capsules for opening 5 mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib granules in sprinkle capsules for opening 7.5 mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Trade Name: Koselugo 10mg Product Name: Selumetinib capsules 10mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Trade Name: Koselugo 25mg Product Name: Selumetinib capsules 25mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	38	Phase 1;Phase 2	United States;Spain;Russian Federation;Germany;Netherlands;Italy
4	EUCTR2020-005608-20-DE (EUCTR)	24/11/2021	09/09/2021	Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE)	A Phase I/II, Single-Arm, Open label Study to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of the Selumetinib Granule Formulation in Children Aged = 1 to < 7 Years with Neurofibromatosis Type 1 (NF1) Related Symptomatic, Inoperable Plexiform Neurofibromas (PN) (SPRINKLE) - SPRINKLE	Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Not possible to specify	Product Name: Selumetinib granules in sprinkle capsules for opening 5 mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib granules in sprinkle capsules for opening 7.5 mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib capsules 10mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib capsules 25mg Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	44	Phase 1;Phase 2	United States;Spain;Russian Federation;Netherlands;Germany;Italy;Japan
5	EUCTR2020-005607-39-ES (EUCTR)	05/10/2021	23/06/2021	Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas	A Phase III, Multicentre, International Study with a Parallel, Randomised, Double blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants with NF1 who have Symptomatic, Inoperable Plexiforn Neurofibromas (KOMET) - KOMET	Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Selumetinib 10mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib 25mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	146	Phase 3	United States;Spain;Russian Federation;Italy;France;Canada;Brazil;Poland;Australia;Germany;Netherlands;China;Japan
6	EUCTR2020-005607-39-IT (EUCTR)	08/09/2021	18/10/2021	Efficacy and Safety of Selumetinib in Adults with NF1 who have Symptomatic, Inoperable Plexiform Neurofibromas	A Phase III, Multicentre, International Study with a Parallel, Randomised, Double blind, Placebo controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants with NF1 who have Symptomatic, Inoperable Plexiforn Neurofibromas (KOMET). - KOMET	Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Selumetinib 25mg capsule Product Code: [AZD6244] INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Product Name: Selumetinib 10mg capsule Product Code: [AZD6244] INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate	ASTRAZENECA AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	146	Phase 3	United States;Spain;Russian Federation;Italy;France;Canada;Brazil;Poland;Australia;Germany;Netherlands;China;Japan
7	EUCTR2020-005648-52-PL (EUCTR)	31/05/2021	26/04/2021	Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Toxicity of Selumetinib in Adolescent Children with Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN)	A Phase I, Single-Arm, Sequential Study to Evaluate the Effect of Food on the Gastrointestinal Toxicity and Pharmacokinetics of Selumetinib after Multiple Doses in Adolescent Children with Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) - Selumetinib Gastrointestinal Toxicity Study (Selumetinib GI Tox Study)	Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibromas (PN) MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850;Therapeutic area: Not possible to specify	Trade Name: Koselugo 10mg Product Name: Selumetinib 10mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate Trade Name: Koselugo 25mg Product Name: Selumetinib 25mg capsule Product Code: AZD6244 INN or Proposed INN: Selumetinib Other descriptive name: selumetinib hyd-sulfate	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 1	United States;Spain;Poland;Russian Federation
8	NCT04166409 (ClinicalTrials.gov)	January 3, 2020	15/11/2019	A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma	A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)	Low Grade Astrocytoma;Low Grade Glioma;Metastatic Low Grade Astrocytoma;Metastatic Low Grade Glioma	Procedure: Biospecimen Collection;Drug: Carboplatin;Procedure: Magnetic Resonance Imaging;Other: Quality-of-Life Assessment;Other: Questionnaire Administration;Drug: Selumetinib Sulfate;Drug: Vincristine Sulfate	National Cancer Institute (NCI)	NULL	Recruiting	2 Years	21 Years	All	220	Phase 3	United States;Canada;Puerto Rico
9	NCT03871257 (ClinicalTrials.gov)	October 4, 2019	11/3/2019	A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma	A Phase 3 Randomized Study of Selumetinib Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)	Low Grade Glioma;Neurofibromatosis Type 1;Visual Pathway Glioma	Drug: Carboplatin;Procedure: Magnetic Resonance Imaging;Other: Quality-of-Life Assessment;Other: Questionnaire Administration;Drug: Selumetinib Sulfate;Drug: Vincristine Sulfate	National Cancer Institute (NCI)	NULL	Recruiting	2 Years	21 Years	All	290	Phase 3	United States;Canada;Puerto Rico
10	NCT03433183 (ClinicalTrials.gov)	October 2, 2019	29/1/2018	SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors	SARC031: A Phase 2 Trial of the MEK Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Combination With the mTOR Inhibitor Sirolimus for Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumors	Malignant Peripheral Nerve Sheath Tumors;Neurofibromatosis 1	Drug: Selumetinib;Drug: Sirolimus	Sarcoma Alliance for Research through Collaboration	United States Department of Defense;AstraZeneca	Active, not recruiting	12 Years	N/A	All	21	Phase 2	United States
11	EUCTR2017-002635-41-GB (EUCTR)	26/09/2018	19/06/2019	A PAEDIATRIC PHASE I/II STUDY OF INTERMITTENT DOSING OF THE MEK-1 INHIBITOR SELUMETINIB IN CHILDREN WITH NEUROFIBROMATOSIS TYPE-1 AND INOPERABLE PLEXIFORM NEUROFIBROMA AND/OR PROGRESSIVE OPTIC PATHWAY GLIOMA	A paediatric phase I/II study of intermittent dosing of the MEK-1 inhibitor selumetinib in children with neurofibromatosis type-1 and inoperable plexiform neurofibroma and/or progressive optic pathway glaiom - Intermittent Selumetinib dosing Phase I/II study Childhood NF1 tumours	Neurofibromatosis type 1 associated plexiform neurofibromas Neurofibromatosis type 1 associated progressive or relapsed optic pathway glioma MedDRA version: 20.0;Level: LLT;Classification code 10029270;Term: Neurofibromatosis, type 1 (von Recklinghausen's disease);System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10065866;Term: Plexiform neurofibroma;System Organ Class: 100000004864 MedDRA version: 20.0;Classification code 10030935;Term: Optic nerve glioma;System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Selumetinib INN or Proposed INN: selumetinib sulfate Other descriptive name: Selumetinib Hyd-sulphate	Great Ormond Street Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	38	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
12	NCT03105258 (ClinicalTrials.gov)	May 1, 2017	23/3/2017	Selumetinib Pilot Study for Cutaneous Neurofibromas	Pilot Study of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) for Adults With Neurofibromatosis Type 1 (NF1) and Cutaneous Neurofibromas (cNF)	Neurofibromatosis Type 1;Cutaneous Neurofibroma	Drug: Selumetinib	University of Alabama at Birmingham	National Cancer Institute (NCI)	Not yet recruiting	18 Years	N/A	All	24	Phase 2	United States
13	NCT02839720 (ClinicalTrials.gov)	April 11, 2017	20/7/2016	Selumetinib in Treating Patients With Neurofibromatosis Type 1 and Cutaneous Neurofibroma	Pilot Study of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) for Adults With Neurofibromatosis Type 1 (NF1) and Cutaneous Neurofibromas (CNF)	Cutaneous Neurofibroma;Neurofibromatosis Type 1;Optic Nerve Glioma	Other: Laboratory Biomarker Analysis;Drug: Selumetinib Sulfate	National Cancer Institute (NCI)	NULL	Active, not recruiting	18 Years	N/A	All	24	Phase 2	United States
14	NCT03109301 (ClinicalTrials.gov)	April 7, 2017	11/4/2017	Mitogen Activated Protein Kinase Kinase (MEK1/2) Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in People With Neurofibromatosis Type 1 (NF1) Mutated Gastrointestinal Stromal Tumors (GIST)	A Phase II Trial of the Mitogen Activated Protein Kinase Kinase (MEK1/2) Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Patients With Neurofibromatosis Type 1 (NF1) Mutated Gastrointestinal Stromal Tumors (GIST)	Neoplasms, Nerve Tissue;Neurofibromatosis 1;Heredodegenerative Disorders, Nervous System;Peripheral Nervous System Diseases	Drug: Selumetinib (AZD6244 hyd sulfate) 50mg/dose;Drug: Selumetinib (AZD6244 hyd sulfate) 25mg/m2	National Cancer Institute (NCI)	NULL	Withdrawn	3 Years	99 Years	All	0	Phase 2	United States
15	NCT02407405 (ClinicalTrials.gov)	January 7, 2016	2/4/2015	MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas	Phase II Trial of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas	Neurofibromatosis 1 (NF1);Plexiform Neurofibromas (PN)	Drug: Selumetinib	National Cancer Institute (NCI)	NULL	Active, not recruiting	18 Years	N/A	All	36	Phase 2	United States
16	NCT02644512 (ClinicalTrials.gov)	December 2015	31/12/2015	MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas	Phase II Trial of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas	Neurofibromatosis 1;Plexiform Neurofibromas	Drug: Selumetinib	National Cancer Institute (NCI)	NULL	Recruiting	18 Years	99 Years	Both	50	Phase 2	United States
17	NCT01362803 (ClinicalTrials.gov)	September 21, 2011	27/5/2011	AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors	A Phase I/II Study of the Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor Selumetinib (AZD6244; Hydrogen Sulfate in Children With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)	Neurofibromatosis 1;Neurofibromatosis Type 1;NF1;Neurofibroma, Plexiform	Drug: AZD6244	National Cancer Institute (NCI)	NULL	Active, not recruiting	2 Years	18 Years	All	99	Phase 1/Phase 2	United States
18	NCT00846430 (ClinicalTrials.gov)	October 2008	16/1/2009	Medical Treatment of High-Risk Neurofibromas	Medical Treatment of High-Risk Neurofibromas in Patients With Type 1 Neurofibromatosis: A Clinical Trial of Sequential Medical Therapies	Neurofibromatosis 1	Drug: Peg-Interferon alpha-2b;Drug: Celecoxib (Celebrex);Drug: Temozolomide (temodar);Drug: Vincristine Sulfate (Oncovin)	Spectrum Health Hospitals	NULL	Completed	2 Years	30 Years	All	11	Phase 2	United States
19	NCT00352495 (ClinicalTrials.gov)	June 2006	13/7/2006	Vinblastine and Carboplatin in Treating Young Patients With Newly Diagnosed or Recurrent Low-Grade Glioma	A Phase I Study of Vinblastine in Combination With Carboplatin for Children With Newly Diagnosed and Recurrent Low-Grade Gliomas	Brain and Central Nervous System Tumors;Neurofibromatosis Type 1	Drug: carboplatin;Drug: vinblastine sulfate	Children's Oncology Group	National Cancer Institute (NCI)	Completed	N/A	21 Years	Both	26	Phase 1	United States;Canada

先頭へ

36. 表皮水疱症

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臨床試験数 : 163 /  薬物数 : 185 - (DrugBank : 46) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 125

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04644627 (ClinicalTrials.gov)	December 1, 2020	20/11/2020	Topical Gentamicin Nonsense Suppression Therapy of EB	TOPICAL GENTAMICIN TREATMENT OF PATIENTS WITH EPIDERMOLYSIS BULLOSA DUE TO NONSENSE MUTATIONS	Epidermolysis Bullosa	Drug: Gentamicin Sulfate	Oslo University Hospital	NULL	Completed	N/A	N/A	All	4	Phase 1/Phase 2	Norway
2	EUCTR2020-002337-15-NO (EUCTR)	16/09/2020	29/06/2020	TOPICAL GENTAMICIN TREATMENT OF PATIENTS WITH EPIDERMOLYSIS BULLOSA	TOPICAL GENTAMICIN TREATMENT OF PATIENTS WITH EPIDERMOLYSIS BULLOSA DUE TO NONSENSE MUTATIONS (THE GENTELBULL STUDY) - GENTELBULL	Epidermolysis bullosa caused by nonsense mutations or splice site mutations;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Infectogenta Product Name: Gentamicin sulfate 0.1% ointment	Oslo University Hospital	NULL	Not Recruiting			Female: yes Male: yes	6	Phase 2	Norway
3	NCT04140786 (ClinicalTrials.gov)	October 31, 2019	23/10/2019	Optimizing IV Gentamicin in JEB	Optimization of Intravenous Gentamicin Treatment to Restore Functional Laminin 332 in JEB Patients With Nonsense Mutations	Junctional Epidermolysis Bullosa	Drug: Gentamicin Sulfate, Injectable	University of Southern California	NULL	Recruiting	30 Days	N/A	All	6	Phase 1/Phase 2	United States
4	NCT03526159 (ClinicalTrials.gov)	June 1, 2018	17/4/2018	Gentamicin for Junctional Epidermolysis Bullosa	A Pilot Study of the Restoration of Functional Laminin 332 in JEB Patients With Nonsense Mutations After Topical and Intravenous Gentamicin Treatment	Junctional Epidermolysis Bullosa	Drug: Gentamicin Sulfate	University of Southern California	NULL	Recruiting	N/A	N/A	All	6	Phase 1/Phase 2	United States
5	NCT03012191 (ClinicalTrials.gov)	February 2, 2017	4/1/2017	Gentamicin for RDEB	Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa Patients With Nonsense Mutations	Recessive Dystrophic Epidermolysis Bullosa	Drug: Gentamicin Sulfate	University of Southern California	NULL	Completed	N/A	N/A	All	6	Phase 1/Phase 2	United States

先頭へ

46. 悪性関節リウマチ

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臨床試験数 : 4,356 /  薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2015-000538-31-DE (EUCTR)	01/06/2015	07/04/2015	Application into the joint of opioids in chronic arthritis of the knee joint	NEUORIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint - Neuroimpa - knee joint	chronic arthritis of the knee joint effusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA. MedDRA version: 18.0;Level: LLT;Classification code 10067624;Term: Knee arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Morphine Hexal INN or Proposed INN: Morphinsulfat Other descriptive name: MORPHINE SULFATE Trade Name: Triam 40 mg Lichtenstein INN or Proposed INN: TRIAMCINOLONACETONID Other descriptive name: TRIAMCINOLONACETONID EP	Charité University medicine Berlin	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Germany
2	EUCTR2011-004720-35-NO (EUCTR)	04/05/2015	26/01/2015	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Metex INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Imurel INN or Proposed INN: IMUREL Other descriptive name: AZATHIOPRINE Trade Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN INN or Proposed INN: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Plaquenil Other descriptive name: HYDROXYCHLOROQUINE SULFATE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Finland;Denmark;Norway;Sweden
3	EUCTR2011-004720-35-FI (EUCTR)	10/09/2014	09/09/2014	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: METHOTREXATE DISODIUM Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Oxiklorin Product Code: 118-42-3 Other descriptive name: HYDROXYCHLOROQUINE SULFATE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Finland;Denmark;Sweden
4	ChiCTR-TRC-14004520	2014-05-01	2014-04-13	To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water	To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water metabolism	rheumatoid arthritis	two:Methotrexate, hydroxychloroquine sulfate pills and NSAIDs in both groups; Sanhuang Yinong decoction will be give in the experimental group;RA patients:NA;	General Hospital of Chengdu Military Region	NULL	Recruiting	45	65	Both	two:240;RA patients:40;	I (Phase 1 study)	China
5	EUCTR2013-003658-26-NL (EUCTR)	13/11/2013	18/10/2013	Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort Study	Treat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort Study	Early Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Prednison Product Name: Prednison INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Plaquenil Product Name: hydroxycholoquine INN or Proposed INN: hydroxychloroquine sulfate Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: Sulfasalazine Product Name: Sulfasalazine INN or Proposed INN: Sulfasalazine Other descriptive name: SULFASALAZINE	VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
6	EUCTR2009-015740-42-DE (EUCTR)	12/05/2010	12/01/2010	A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO	A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: Prednisolon Product Code: Prednisolon INN or Proposed INN: PREDNISOLONE Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin Other descriptive name: AZATHIOPRINE Trade Name: Immunosporin Product Name: Immunosporin INN or Proposed INN: CICLOSPORIN Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: GOLIMUMAB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Product Name: Quensyl Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: REMICADE Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Lantarel Product Name: Lantarel INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Lantarel Trade Name: Arava Product Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: A	Universitätsklinkum Erlangen	NULL	Not Recruiting			Female: yes Male: yes	318	Phase 3	Germany
7	ChiCTR2100043373	2009-07-01	2021-02-12	Clinical study of Hydroxychloroquine Sulfate and sulfasalazine in the treatment of active rheumatoid arthritis	Clinical study of Hydroxychloroquine Sulfate and sulfasalazine in the treatment of active rheumatoid arthritis	rheumatoid arthritis	group one:HCQ(200mg/d)+MTX;group two:HCQ(400mg/d)+MTX;group three:HCQ(200mg/d)+SASP+MTX;group four:SASP+MTX;	Renji Hospital, Shanghai Jiaotong University School of Medicine	NULL	Completed			Both	group one:50;group two:50;group three:50;group four:50;	Phase 4	china
8	EUCTR2006-006186-16-NL (EUCTR)	30/01/2007	16/07/2007	IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED	IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED	rheumatoid arthritis and undifferentiated arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Methotrexate Product Code: MTX INN or Proposed INN: METHOTREXATE Product Name: Prednisone INN or Proposed INN: PREDNISONE Product Name: Sulfasalazine INN or Proposed INN: SULFASALAZINE Trade Name: hydroxychloroquine Product Name: hydroxychloroquine Product Code: HCQ INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE Trade Name: Humira Product Name: adalimumab	Leiden University Medical Center, department of rheumatology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands

先頭へ

49. 全身性エリテマトーデス

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臨床試験数 : 993 /  薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	ChiCTR1800019308	2018-11-12	2018-11-04	Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus	Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus	systemic lupus erythematosus	NHMX:One kind of non-steroid anti-inflammatory drugs combines with hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine (maintaining the drug concentration between 30-90ug/l);control:hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine(maintaining the drug concentration between 30-90ug/l);	The Third Affiliated Hospital, Southern Medical University	NULL	Recruiting	18	65	Both	NHMX:75;control:75;		China
2	NCT01551069 (ClinicalTrials.gov)	March 2012	8/3/2012	Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion	A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion	Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus	Drug: hydroxychloroquine (Z0188);Drug: Placebo	Sanofi	NULL	Completed	18 Years	N/A	Both	103	Phase 3	Japan

53. シェーグレン症候群

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臨床試験数 : 305 /  薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-002470-32-NL (EUCTR)	12/12/2022	23/07/2021	NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients	NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY	Primary Sjögren’s syndrome (pSS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: PLAQUENIL Product Name: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: Mycophenolate mofetil TEVA Product Name: mycophenolate mofetil INN or Proposed INN: Mycophenolate mofetil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: Arava Product Name: Leflunomide INN or Proposed INN: LEFLUNOMIDE	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 2	Netherlands;Italy
2	ChiCTR2200057578	2022-03-01	2022-03-15	Tofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trial	Tofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trial	Sjogren Syndrome	Control group:Same dose of hydroxychloroquine sulfate as before;Intervention group:Tofacitinib 5mg bid po+the same dose of hydroxychloroquine sulfate as before;	Ningbo Medical Center Lihuili Hospital	NULL	Pending	15	70	Both	Control group:60;Intervention group:60;	Phase 4	China
3	EUCTR2019-002470-32-NO (EUCTR)	14/12/2021	26/08/2021	NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients	NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY	Primary Sjögren’s syndrome (pSS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: PLAQUENIL Product Name: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: Mycophenolate mofetil TEVA Product Name: mycophenolate mofetil INN or Proposed INN: Mycophenolate mofetil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: Arava Product Name: Leflunomide INN or Proposed INN: LEFLUNOMIDE	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 2	Netherlands;Norway;Italy
4	EUCTR2019-002470-32-IT (EUCTR)	05/10/2021	27/01/2022	Nuovi end-points clinici in pazienti con sindrome di Sjögren primaria (pSS): uno studio interventistico basato sulla stratificazione dei pazienti.	NEw Clinical End-points in patients with primary Sjögren's Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY	Primary Sjögren's syndrome (pSS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Arava Product Name: Leflunomide Product Code: [Leflunomide] INN or Proposed INN: LEFLUNOMIDE Trade Name: Mycophenolate mofetil TEVA Product Name: mycophenolate mofetil Product Code: [mycophenolate mofetil] INN or Proposed INN: MICOFENOLATO MOFETILE Trade Name: PLAQUENIL Product Name: Hydroxychloroquine Product Code: [Hydroxychloroquine] INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE	ASSITANCE PUBLIQUE DES HOPITAUX DE PARIS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 2	France;Greece;Spain;Norway;Netherlands;United Kingdom;Italy;Sweden
5	ITMCTR2000003900	2020-09-08	2020-09-08	Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial	Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial	Primary Sjogren's syndrome	Control group:Hydroxychloroquine sulfate tablets 200ml bid po;Experimental group:Bushen Qingre Runzao Decoction 200ml bid po;	China-Japan Friendship Hospital	NULL	Recruiting	18	75	Both	Control group:48;Experimental group:48;	N/A	China
6	ChiCTR2000037989	2020-09-08	2020-09-08	Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial	Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial	Primary Sjogren's syndrome	Experimental group:Bushen Qingre Runzao Decoction 200ml bid po;Control group:Hydroxychloroquine sulfate tablets 200ml bid po;	China-Japan Friendship Hospital	NULL	Recruiting	18	75	Both	Experimental group:48;Control group:48;	N/A	China
7	EUCTR2007-005218-38-FR (EUCTR)	31/01/2008	20/11/2007	Essai prospectif Randomisé contre placebo en double aveugle de l’hydroxychloroQUine dans le traitement du syndrome de sJOgren primitif (JOQUER) - JOQUER	Essai prospectif Randomisé contre placebo en double aveugle de l’hydroxychloroQUine dans le traitement du syndrome de sJOgren primitif (JOQUER) - JOQUER	Syndrome de Sjögren primitif MedDRA version: 8.1;Level: PT;Classification code 10042846;Term: Syndrome Sjogren's	Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Sulfate d'hydroxychloroquine	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France

先頭へ

60. 再生不良性貧血

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臨床試験数 : 245 /  薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2011-005152-34-ES (EUCTR)	26/03/2012	22/11/2011	Clinical trial to reduce duration of antibiotic therapy in in-hospital patients with haematological diseases that develop fever and low white blood cell count (neutropenia).	Randomized open label clinical trial directed to optimize the duration of empirical antimicrobial therapy in haematologic patients with febrile neutropenia	In-hospital adult patients diagnosed with acute leukemia, lymphoproliferative syndrome, multiple myeloma, myelodysplastic syndrome, aplastic anemia or who have received autologous or allogeneic transplantation of hematopoietic progenitors, with febrile neutropenia without etiological diagnosis. MedDRA version: 14.0;Level: PT;Classification code 10016288;Term: Febrile neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.0;Level: LLT;Classification code 10066156;Term: Empiric treatment;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	INN or Proposed INN: ACICLOVIR Other descriptive name: ACICLOVIR INN or Proposed INN: AMIKACIN Other descriptive name: AMIKACIN INN or Proposed INN: AMPHOTERICINE B, LIPOSOME Other descriptive name: AMPHOTERICINE B, LIPOSOME INN or Proposed INN: CASPOFUNGIN ACETATE Other descriptive name: CASPOFUNGIN ACETATE INN or Proposed INN: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE Other descriptive name: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE INN or Proposed INN: CIPROFLOXACIN Other descriptive name: CIPROFLOXACIN INN or Proposed INN: TRIMETHOPRIM SULFATE Other descriptive name: TRIMETHOPRIM SULFATE INN or Proposed INN: SULFAMETH	José Miguel Cisneros Herreros	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Spain

64. 血栓性血小板減少性紫斑病

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臨床試験数 : 92 /  薬物数 : 85 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 76

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03237819 (ClinicalTrials.gov)	May 27, 2018	13/6/2017	Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care	Interest of Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care: Multicentric Randomized Controlled Trial	Thrombotic Thrombocytopenic Purpura	Drug: Sulfate, Magnesium;Drug: Placebo - Concentrate	Assistance Publique - Hôpitaux de Paris	NULL	Active, not recruiting	18 Years	N/A	All	74	Phase 3	France

66. IgA腎症

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臨床試験数 : 275 /  薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02942381 (ClinicalTrials.gov)	September 13, 2016	14/10/2016	A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy		IgA Patients;Hydroxychloroquine	Drug: Hydroxychloroquine Sulfate;Drug: Placebo	Peking University First Hospital	NULL	Completed	18 Years	75 Years	All	60	Phase 2	China
2	NCT02765594 (ClinicalTrials.gov)	June 2016	30/4/2016	Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy	Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy:a Single Center Prospective Randomized Controlled Study	Primary IgA Nephropathy	Drug: Hydroxychloroquine Sulfate;Drug: Valsartan	Peking Union Medical College Hospital	NULL	Recruiting	18 Years	60 Years	All	98	Phase 4	China
3	NCT02351752 (ClinicalTrials.gov)	January 2015	27/1/2015	Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study	Renal Division, Peking University First Hospital, Institute of Nephrology, Peking University, Key Laboratory of Renal Disease	Primary IgA Nephropathy	Drug: Hydroxychloroquine Sulfate	LLiu	NULL	Completed	18 Years	75 Years	Both	20	Phase 4	China

85. 特発性間質性肺炎

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臨床試験数 : 627 /  薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04429516 (ClinicalTrials.gov)	December 17, 2020	12/3/2020	Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough	PAciFy Cough: A Multicentre, Double Blind, Placebo Controlled, Crossover Trial of Morphine Sulfate for the Treatment of PulmonAry Fibrosis Cough	Idiopathic Pulmonary Fibrosis	Drug: Morphine Sulfate;Drug: Placebo oral tablet	Royal Brompton & Harefield NHS Foundation Trust	NULL	Recruiting	40 Years	90 Years	All	44	Phase 3	United Kingdom
2	EUCTR2019-003571-19-GB (EUCTR)	21/05/2020	27/02/2020	A multicentre, double blind, placebo controlled, crossover trial of morphine sulphate sulfate for the treatment of PulmonAry Fibrosis Cough (PAciFy Cough Trial)	PAciFy Cough: A multicentre, double blind, placebo controlled, crossover trial of morphine sulfate for the treatment of PulmonAry Fibrosis Cough - PACIFY Cough	Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Morphine Sulfate Product Name: Morphine Sulfate INN or Proposed INN: morphine sulfate	Royal Brompton and Harefield NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	44	Phase 3	United Kingdom

86. 肺動脈性肺高血圧症

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臨床試験数 : 1,205 /  薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03401476 (ClinicalTrials.gov)	May 8, 2017	30/4/2017	Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension	Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: Morphine Sulfate	John Granton	NULL	Unknown status	18 Years	N/A	All	15	Phase 2	Canada

96. クローン病

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臨床試験数 : 2,442 /  薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT01245088 (ClinicalTrials.gov)	January 2011	19/11/2010	Chondroitin Sulfate for Crohn's Disease	A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease	Crohn's Disease	Drug: chondroitin sulfate	University Hospital Case Medical Center	NULL	Withdrawn	18 Years	80 Years	Both	0	Phase 1/Phase 2	United States

111. 先天性ミオパチー

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臨床試験数 : 10 /  薬物数 : 17 - (DrugBank : 5) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 9

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05099107 (ClinicalTrials.gov)	October 25, 2021	15/10/2021	Changes of Motor Function Tests in Congenital Myopathy Subjects Treated With Oral Salbutamol as Compared to no Treatment	COMPIS- Congenital Myopathy Intervention Study. An Open-label, Cross Over, Randomised, Controlled Study Using Oral Salbutamol	Congenital Myopathy;Neuromuscular Diseases;Musculoskeletal Diseases;Nemaline Myopathy;Centronuclear Myopathy;Myosin Storage Myopathy	Drug: Salbutamol (as Salbutamol Sulfate) 2 Mg Oral Tablet;Drug: Salbutamol Only Product in Oral Dose Form	Vastra Gotaland Region	NULL	Enrolling by invitation	6 Years	30 Years	All	20	N/A	Sweden
2	EUCTR2019-001147-51-SE (EUCTR)	31/03/2020	27/09/2019	This is a treatment study for a muscle disorder known as congenital myopathy	Congenital myopathy intervention study - COMPIS	Congenital myopathy MedDRA version: 20.0;Level: PT;Classification code 10062547;Term: Congenital myopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Ventoline tablet 2mg INN or Proposed INN: SALBUTAMOL SULFATE Trade Name: Ventoline oral solution 0,4mg/ml INN or Proposed INN: SALBUTAMOL SULFATE	Västra götalandsregionen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 4	Sweden

218. アルポート症候群

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臨床試験数 : 30 /  薬物数 : 36 - (DrugBank : 15) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 46

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04937907 (ClinicalTrials.gov)	September 8, 2021	17/6/2021	Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)	Efficacy and Safety of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)	Alport Syndrome, X-Linked	Drug: Hydroxychloroquine Sulfate 100 milligram (mg) Tab;Drug: Benazepril hydrochloride 10 milligram (mg) Tab	Shanghai Children's Hospital	NULL	Recruiting	3 Years	18 Years	All	50	Phase 2	China

222. 一次性ネフローゼ症候群

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臨床試験数 : 310 /  薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	ChiCTR1900021757	2019-03-01	2019-03-08	A randomized controlled trial for hydroxychloroquine sulfate in the treatment of idiopathic membranous nephropathy	The efficacy and safety of hydroxychloroquine sulfate in idiopathic membranous nephropathy: A randomized, controlled, Single-center clinical trial	Idiopathic Membranous Nephropathy	Group 1:Supportive treatment+Perindopril 8 mg/day;Group 2:Supportive treatment+Perindopril 8 mg/day+hydroxychloroquine sulfate (200mg 2/d);Group 3:Low dose glucocorticoid (0.5mg/kg.d)+cyclosporine A (valley concentration controlled at 50-100ng/ml);Group 4:Low dose glucocorticoid (0.5mg/kg.d)+cyclosporine A (valley concentration controlled at 50-100ng/ml)+hydroxychloroquine sulfate (200mg 2/d);	Nephrology Division, First Hospital Affiliated to Army Medical University	NULL	Recruiting	18	60	Both	Group 1:55;Group 2:55;Group 3:55;Group 4:55;	Phase 4	China

224. 紫斑病性腎炎

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臨床試験数 : 16 /  薬物数 : 43 - (DrugBank : 21) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 58

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	ChiCTR2200057905	2022-04-01	2022-03-21	A prospective, open, randomized controlled study of hydroxychloroquine sulfate in the treatment of adult Henoch Schonlein purpura nephritis	A prospective, open, randomized controlled study of hydroxychloroquine sulfate in the treatment of adult Henoch Schonlein purpura nephritis	Henoch Schonlein purpura nephritis	Experimental group:Hydroxychloroquine sulfate;Control group:Conventional therapy;	Daping Hospital, Army Medical University	NULL	Recruiting	18		Both	Experimental group:42;Control group:42;	Phase 4	China

226. 間質性膀胱炎（ハンナ型）

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臨床試験数 : 145 /  薬物数 : 156 - (DrugBank : 51) / 標的遺伝子数 : 64 - 標的パスウェイ数 : 146

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03463499 (ClinicalTrials.gov)	September 22, 2017	25/2/2018	The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients	The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients	Interstitial Cystitis	Drug: Hyaluronic Acid and Chondroitin Sulfate	Samsung Medical Center	NULL	Completed	20 Years	N/A	All	62	N/A	Korea, Republic of
2	NCT01813565 (ClinicalTrials.gov)	March 20, 2013	11/3/2013	The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.	The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.	Interstitial Cystitis	Drug: Hyaluronic acid/chondroitin sulfate	Asan Medical Center	NULL	Terminated	20 Years	N/A	All	15	N/A	Korea, Republic of
3	EUCTR2010-021556-25-IT (EUCTR)	24/02/2011	04/11/2010	Phase III, randomized, open-label, multicenter evaluation of efficacy and tolerability `of Ialuril (sodium hyaluronate-chondroitin sulfate) vs. dimethyl sulfoxide (DMSO) in women with interstitial cystitis / painful bladder syndrome (IC / BPS)AscoltaTrascrizione foneticaDizionario - Visualizza dizionario dettagliato - IBSA 01-2010	Phase III, randomized, open-label, multicenter evaluation of efficacy and tolerability `of Ialuril (sodium hyaluronate-chondroitin sulfate) vs. dimethyl sulfoxide (DMSO) in women with interstitial cystitis / painful bladder syndrome (IC / BPS)AscoltaTrascrizione foneticaDizionario - Visualizza dizionario dettagliato - IBSA 01-2010	Interstitial Cystitis MedDRA version: 9.1;Level: HLGT;Classification code 10018188	Trade Name: RIMSO 50 INN or Proposed INN: Dimethyl sulfoxide	IBSA	NULL	Not Recruiting			Female: yes Male: no		Phase 3	Italy
4	NCT00919113 (ClinicalTrials.gov)	July 2009	11/6/2009	Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome	A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Effectiveness and Safety of Uracyst® Compared to Inactive Control in Subjects With Interstitial Cystitis/Painful Bladder Syndrome	Interstitial Cystitis;Painful Bladder Syndrome	Drug: 2% sodium chondroitin sulfate;Drug: Placebo	Watson Pharmaceuticals	NULL	Completed	18 Years	N/A	Female	98	Phase 2	United States

265. 脂肪萎縮症

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臨床試験数 : 112 /  薬物数 : 155 - (DrugBank : 55) / 標的遺伝子数 : 25 - 標的パスウェイ数 : 97

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00028314 (ClinicalTrials.gov)	March 2002	20/12/2001	Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients	A Restrictively Randomized, Open-Label, Controlled, Pilot Study of the Effect of a Thymidine Analogue Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral Fat Wasting	HIV Infections;Lipodystrophy;Wasting Disease	Drug: Abacavir sulfate;Drug: Atazanavir/Ritonavir;Drug: Lopinavir/Ritonavir;Drug: Nevirapine	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Completed	13 Years	N/A	Both	150	N/A	United States
2	NCT00021463 (ClinicalTrials.gov)	April 2001	14/7/2001	Changing to Nonprotease Inhibitor Treatment to Improve Side Effects	Phase II, Randomized, Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic Abnormalities	HIV Infections;Lipodystrophy	Drug: Abacavir sulfate, Lamivudine and Zidovudine;Drug: Abacavir sulfate;Drug: Efavirenz;Drug: Nevirapine	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Completed	13 Years	N/A	Both	342	Phase 2	United States
3	NCT00005764 (ClinicalTrials.gov)	May 2000	30/5/2000	A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients	Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)	HIV Infections;Lipodystrophy	Drug: Lamivudine/Zidovudine;Drug: Abacavir sulfate;Drug: Lamivudine	Glaxo Wellcome	NULL	Completed	18 Years	N/A	Both	100	Phase 4	United States

296. 胆道閉鎖症

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臨床試験数 : 71 /  薬物数 : 70 - (DrugBank : 39) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 60

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00007033 (ClinicalTrials.gov)	October 2000	6/12/2000	Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease		Alagille Syndrome;Cholestasis;Biliary Atresia	Drug: magnesium gluconate;Drug: magnesium sulfate	National Center for Research Resources (NCRR)	Children's Hospital Medical Center, Cincinnati	Completed	3 Years	18 Years	Both	25	N/A	United States

297. アラジール症候群

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臨床試験数 : 45 /  薬物数 : 21 - (DrugBank : 10) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 5

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00007033 (ClinicalTrials.gov)	October 2000	6/12/2000	Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease		Alagille Syndrome;Cholestasis;Biliary Atresia	Drug: magnesium gluconate;Drug: magnesium sulfate	National Center for Research Resources (NCRR)	Children's Hospital Medical Center, Cincinnati	Completed	3 Years	18 Years	Both	25	N/A	United States

299. 嚢胞性線維症

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臨床試験数 : 1,695 /  薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2016-001785-29-IE (EUCTR)	15/08/2016	10/05/2016	Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF.	Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment	Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Kalydeco INN or Proposed INN: IVACAFTOR Trade Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE Product Name: Flucloxicillin INN or Proposed INN: FLUCLOXACILLIN SODIUM Trade Name: Fortum INN or Proposed INN: CEFTAZIDIME Product Name: Tobramycin INN or Proposed INN: TOBRAMYCIN SULFATE Trade Name: Meropenem INN or Proposed INN: Meropenem Other descriptive name: MEROPENEM Trade Name: Colistin INN or Proposed INN: COLISTIMETHATE SODIUM	St. Vincent's University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Ireland
2	EUCTR2013-004295-35-AT (EUCTR)	30/04/2014	02/04/2014	Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study	Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT	Chronic lung P. Aeruginosa Infection MedDRA version: 16.1;Level: PT;Classification code 10061229;Term: Lung infection;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler INN or Proposed INN: aztreonam Other descriptive name: AZTREONAM LYSINE Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel INN or Proposed INN: COLISTIMETHATE SODIUM Trade Name: TOBI Product Name: Tobi INN or Proposed INN: TOBRAMYCIN SULFATE	Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 4	Austria
3	EUCTR2011-000443-24-NL (EUCTR)	25/04/2013	06/07/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
4	EUCTR2011-000443-24-DK (EUCTR)	14/12/2012	22/07/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
5	EUCTR2011-000441-20-NL (EUCTR)	11/09/2012	06/07/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom
6	EUCTR2011-000441-20-BG (EUCTR)	13/06/2012	03/05/2012	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
7	EUCTR2011-000443-24-SE (EUCTR)	24/05/2012	07/06/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
8	EUCTR2011-000441-20-IE (EUCTR)	02/05/2012	26/05/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Code: TOBI INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
9	EUCTR2011-000443-24-IT (EUCTR)	10/04/2012	19/03/2012	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin Product Code: NA INN or Proposed INN: AMIKACIN SULFATE	INSMED INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	250		Greece;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Canada;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
10	EUCTR2011-000441-20-DK (EUCTR)	29/03/2012	22/07/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
11	EUCTR2011-000441-20-BE (EUCTR)	30/01/2012	25/05/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI Product Code: N/A INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany
12	EUCTR2011-000443-24-BE (EUCTR)	30/01/2012	25/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
13	EUCTR2011-000443-24-PL (EUCTR)	20/01/2012	06/10/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
14	EUCTR2011-000443-24-DE (EUCTR)	11/10/2011	30/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
15	EUCTR2011-000442-38-BG (EUCTR)	03/10/2011	05/07/2011	Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden
16	EUCTR2011-000443-24-BG (EUCTR)	03/10/2011	28/07/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
17	EUCTR2011-000441-20-IT (EUCTR)	01/10/2011	08/03/2012	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE Trade Name: Tobi INN or Proposed INN: TOBRAMYCIN	INSMED INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy
18	EUCTR2011-000442-38-ES (EUCTR)	21/09/2011	11/11/2011	Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaESTUDIO ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE™ EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Poland;Spain;Ukraine;Australia;Bulgaria;New Zealand;Sweden
19	EUCTR2011-000441-20-DE (EUCTR)	19/09/2011	30/05/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
20	EUCTR2011-000443-24-GR (EUCTR)	09/08/2011	23/06/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
21	EUCTR2011-000443-24-IE (EUCTR)	05/08/2011	26/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
22	EUCTR2011-000441-20-GB (EUCTR)	03/08/2011	24/05/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
23	EUCTR2011-000443-24-GB (EUCTR)	03/08/2011	24/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
24	EUCTR2011-000443-24-FR (EUCTR)	28/07/2011	31/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
25	EUCTR2011-000443-24-AT (EUCTR)	22/07/2011	27/06/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
26	EUCTR2011-000441-20-AT (EUCTR)	19/07/2011	21/06/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
27	EUCTR2011-000441-20-GR (EUCTR)	15/07/2011	22/06/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
28	EUCTR2011-000441-20-SK (EUCTR)	04/07/2011	25/11/2014	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
29	EUCTR2011-000443-24-SK (EUCTR)	04/07/2011	20/02/2014	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Germany;New Zealand;Sweden;United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands
30	EUCTR2011-000441-20-HU (EUCTR)	29/06/2011	20/04/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
31	EUCTR2011-000443-24-HU (EUCTR)	29/06/2011	11/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
32	NCT01755455 (ClinicalTrials.gov)	June 2011	19/12/2012	Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis	Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis	Cystic Fibrosis;Anemia, Iron-Deficiency	Drug: Ferrous sulfate 325mg;Drug: Placebo	Dartmouth-Hitchcock Medical Center	NULL	Completed	18 Years	70 Years	All	22	N/A	United States
33	EUCTR2006-006980-22-BE (EUCTR)	27/06/2007	19/07/2007	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin sulfate	Transave, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60		Hungary;Belgium
34	EUCTR2011-000442-38-PL (EUCTR)		01/08/2011	Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden
35	EUCTR2006-006980-22-PL (EUCTR)		22/08/2007	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Transave, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Slovakia;Belgium;Poland

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