Water ( DrugBank: Water )


21 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3
5進行性核上性麻痺1
6パーキンソン病8
13多発性硬化症/視神経脊髄炎1
17多系統萎縮症2
22もやもや病1
35天疱瘡1
46悪性関節リウマチ3
53シェーグレン症候群1
57特発性拡張型心筋症1
63特発性血小板減少性紫斑病1
65原発性免疫不全症候群1
67多発性嚢胞腎3
78下垂体前葉機能低下症1
84サルコイドーシス1
96クローン病1
97潰瘍性大腸炎6
206脆弱X症候群1
226間質性膀胱炎(ハンナ型)1
278巨大リンパ管奇形(頚部顔面病変)1
299嚢胞性線維症12

2. 筋萎縮性側索硬化症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
1NCT03039673
(ClinicalTrials.gov)
June 19, 201731/1/2017MIROCALS: Modifying Immune Response and OutComes in ALSEfficacy and Safety of Low-dose IL-2 (Ld-IL-2) as a Treg Enhancer for Controlling Neuro-inflammation in Newly Diagnosed Amyotrophic Lateral Sclerosis (ALS) Patients: A Randomized, Double-blind, Placebo- Controlled, Phase-II Proof of Concept/ Proof of Mechanism Clinical TrialAmyotrophic Lateral SclerosisDrug: Riluzole;Drug: IL-2;Drug: 5% glucose water solutionCentre Hospitalier Universitaire de NimesNULLCompleted18 Years75 YearsAll304Phase 2France;United Kingdom
2JPRN-UMIN000019111
2015/10/0101/10/2015CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking.CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking. - The sarcopenia improvement effect by Abound (TM) drinking against ALS Amyotrophic lateral sclerosisAbound(TM)
1,Take one pack twice a day in the moring and evening
2,Drinking was dissolved in water 240 ~ 300ml
3,Before meals, after meals does not matter
4,12 weeks
National Hospital Organization Takasaki General Medical CenterNULLRecruitingNot applicableNot applicableMale and Female20Not selectedJapan
3JPRN-UMIN000015054
2014/09/2104/09/2014An investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosisAn investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosis - An investigator initiated clinical trial in healthy adults of WN1316 Amyotrophic Lateral Sclerosis (ALS)WN1316 solution 5mL is administered single dose orally.
The dosage of WN1316 is 60 micrograms in step 1, 180 micrograms in step 2, 600 micrograms in step 3.

Placebo (Distilled water) 5 mL is administered single dose orally.
Clinical Research Hospital TokyoNULLComplete: follow-up complete20years-old35years-oldMale24Not selectedJapan

5. 進行性核上性麻痺


臨床試験数 : 89 薬物数 : 107 - (DrugBank : 40) / 標的遺伝子数 : 65 - 標的パスウェイ数 : 108
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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agemax
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PhaseCountries
1JPRN-UMIN000008959
2012/11/0116/10/2012Trial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsyTrial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsy - Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in MSA and PSP Multiple system atrophy(MSA)Progressive supranuclear palsy (PSP)hydrogen water
pseudo-water (nitrogen filling water)
Juntendo University School of Medicine, Department of NeurologyNULLComplete: follow-up complete20years-old80years-oldMale and Female40Phase 1Japan

6. パーキンソン病


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.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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agemin
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agemax
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size
PhaseCountries
1ChiCTR1900025894
2019-09-112019-09-12Parallel randomized controlled trial for Shengyang Yiwei Granule in the treatment of early Parkinson's diseaseParallel randomized controlled trial for Shengyang Yiwei Granule in the treatment of early Parkinson's disease parkinson diseaseexperimental group:Parkinson's disease routine medication, plus Shengyang Yiwei granules, water blunt, one dose, morning and evening;control group:Parkinson's disease routine medication, add Buzhong Yiqi granules, water blunt, one dose, morning and evening;Kaida WangNULLRecruitingBothexperimental group:45;control group:23;China
2ITMCTR1900002593
2019-09-112019-09-12Parallel randomized controlled trial for Shengyang Yiwei Granule in the treatment of early Parkinson's diseaseParallel randomized controlled trial for Shengyang Yiwei Granule in the treatment of early Parkinson's disease parkinson diseaseexperimental group:Parkinson's disease routine medication, plus Shengyang Yiwei granules, water blunt, one dose, morning and evening;control group:Parkinson's disease routine medication, add Buzhong Yiqi granules, water blunt, one dose, morning and evening;Kaida WangNULLRecruitingBothexperimental group:45;control group:23;China
3JPRN-UMIN000019654
2015/11/0606/11/2015The effect of rich-hydrogen water drinking to gut peptideThe effect of rich-hydrogen water drinking to gut peptide - The effect of rich-hydrogen water drinking to gut peptide Parkinson's disease, healthy controlhydrogen water
natural water
Nagoya graduate school of medicine universityNULLPending20years-old80years-oldMale and Female40Not applicableJapan
4JPRN-UMIN000019090
2015/11/0401/11/2015Reduced form of CoenzymeQ10 for Parkinson's disease - open trial of dose finding test and combination with hydrogen waterReduced form of CoenzymeQ10 for Parkinson's disease - open trial of dose finding test and combination with hydrogen water - Dose finding test of reduced form of Coenzyme Q10 for Parkinson's disease Parkinson's diseasereduced form of CoQ10 300mg 16weeks
reduced form of CoQ10 600mg 16weeks
reduced form of CoQ10 600mg 16weeks
hydrogen water 500ml(Suisosui 7.0) 16weeks
Juntendo University Koshigaya HospitalNULLComplete: follow-up complete20years-old80years-oldMale and Female45Not selectedJapan
5JPRN-UMIN000010014
2013/02/2813/02/2013Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson DiseaseRandomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease - Randomized Double-blind, Placebo-controlled trial on hydrogen water in Parkinson Disease Parkinson's disesasehydrogen water made by "Suisosui5.0"
placebo-water (nitrogen filling water)
Juntendo University School of Medicine, NeurologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female200Not selectedJapan
6JPRN-UMIN000007497
2010/01/0114/03/2012Trial of molecular hydrogen water in Parkinson diseaseTrial of molecular hydrogen water in Parkinson disease - Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in Parkinson Disease Parkinson diseaseThe subjects should make 1000 ml of molecular hydrogen water which contains 1.6 ppm dissolved hydrogen by Aquerable, and consume for 48 weeks.
Placebo water which is not contained molecular hydrogen water made from pseudo-machine. The subjects consume for48 weeks.
Department of Neurology, Juntendo University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female18Not applicableJapan
7NCT00024622
(ClinicalTrials.gov)
March 15, 200223/9/2001PET Scanning in Parkinson s DiseasePositron Emission Tomography (PET) Scanning in Dopamine Disorders: Parkinson's Disease and SchizophreniaSchizophrenia;Parkinson's DiseaseDrug: 18F-Fluoro-L-dopa;Drug: O-15 WaterNational Institute of Mental Health (NIMH)NULLRecruiting18 Years90 YearsAll580United States
8NCT00001258
(ClinicalTrials.gov)
November 26, 19933/11/1999Studies of Frontal Lobe Brain Functioning in SchizophreniaStudies of Frontal Lobe Function During Cognitive Stimulation as Measured With Oxygen-15 Water Positron Emission Tomography in Normal Subjects and Patients With Neuropsychiatric DisordersHealthy Subjects;Schizophrenia;Parkinson DiseaseDrug: Oxygen-15 WaterNational Institute of Mental Health (NIMH)NULLCompleted18 Years90 YearsAll1039United States

13. 多発性硬化症/視神経脊髄炎


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.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1JPRN-UMIN000043910
2021/06/0101/06/2021Association between brain atrophy and intestinal permeability in patients with multiple sclerosisAssociation between brain atrophy and intestinal permeability in patients with multiple sclerosis - Brain atrophy and intestinal permeability in MS multiple sclerosisA standard solution of lactulose (5 g) and mannitol (2 g)in 500 mL of tap water was ingested before bed. Urine was collected the following morning in a container (with 5 mL of thymol solution).Department of Neurology and Neurological Science, Tokyo Medical and Dental UniversityNULLPending18years-old80years-oldMale and Female40Not selectedJapan

17. 多系統萎縮症


臨床試験数 : 119 薬物数 : 138 - (DrugBank : 44) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 111
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT02149901
(ClinicalTrials.gov)
October 201426/5/2014Water and Sudafed in Autonomic FailureEffect of Drinking Water on the Pressor Response to Pseudoephedrine in Patients With Autonomic FailureShy-Drager Syndrome;Multiple System AtrophyDrug: Pseudoephedrine + 480 ml water;Drug: Pseudoephedrine + 50 ml water;Other: Placebo + 480 ml water (optional);Other: Placebo + 50 ml water (optional)Vanderbilt UniversityNational Heart, Lung, and Blood Institute (NHLBI);National Center for Advancing Translational Science (NCATS)Terminated18 Years80 YearsAll35Early Phase 1United States
2JPRN-UMIN000008959
2012/11/0116/10/2012Trial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsyTrial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsy - Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in MSA and PSP Multiple system atrophy(MSA)Progressive supranuclear palsy (PSP)hydrogen water
pseudo-water (nitrogen filling water)
Juntendo University School of Medicine, Department of NeurologyNULLComplete: follow-up complete20years-old80years-oldMale and Female40Phase 1Japan

22. もやもや病


臨床試験数 : 17 薬物数 : 22 - (DrugBank : 17) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 45
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1JPRN-jRCTs031200402
23/04/202108/03/2021Search for abnormalities of fundus blood vessels in moyamoya diseaseSearch for abnormalities of fundus blood vessels in moyamoya disease Moyamoya disease
Moyamoya disease
For fluorescein fundus angiography, 500 mg of fluorescein (5 ml vial of aqueous solution containing 500 mg of fluorescein) and 25 mg of Ophthagreen (2 ml of blue indocyanine green) are dissolved in 2 ml of distilled water for injection and injected through the forearm of the elbow vein. In daily practice, diabetic retinopathy can be treated by using a diabetic retinal imaging system (optos). In daily practice, it is used for the diagnosis of diabetic retinopathy, uveitis, occlusive retinal vascular disease, and age-related macular degeneration.Akiyama HideoNULLRecruiting>= 20age oldNot applicableBoth50N/AJapan

35. 天疱瘡


臨床試験数 : 99 薬物数 : 124 - (DrugBank : 36) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1EUCTR2013-000211-24-DE
(EUCTR)
01/10/201308/07/2013immunoglobulin infusion as adjuvant therapy in patients with Pemphigus VulgarisA multicenter, randomized, placebo-controlled, double-blind proof of concept study to evaluate the efficacy and safety of the human normal immunoglobulin Intratect® 5% for intravenous use as adjuvant therapy in patients with Pemphigus Vulgaris - IMAT-PV patients with Pemphigus vulgaris
MedDRA version: 16.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Intratect 5%
Product Name: Intratect
Other descriptive name: WATER FOR INJECTION
Other descriptive name: GLYCINE
Ruprecht-Karls-University HeidelbergNULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany

46. 悪性関節リウマチ


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.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1ChiCTR-TRC-14004520
2014-05-012014-04-13To 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 waterTo 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 arthritistwo: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 RegionNULLRecruiting4565Bothtwo:240;RA patients:40;I (Phase 1 study)China
2ChiCTR-ONRC-13003578
2013-09-012013-09-09Agkistrodon different formulations inflammatory and analgesic effects on rheumatoid arthritis clinical studyAgkistrodon different formulations inflammatory and analgesic effects on rheumatoid arthritis clinical study Rheumatoid arthritisThe water decoction group of Agkistrodon:Taking the water decoction of Agkistrodon;Agkistrodon liquor:Taking Agkistrodon liquor agents;Agkistrodon pulvis:Taking the Agkistrodon pulvis;Control group:Taking placebo;Zhejiang Chinese Medical UniversityNULLCompleted1865BothThe water decoction group of Agkistrodon:30;Agkistrodon liquor:30;Agkistrodon pulvis:30;Control group:30;I (Phase 1 study)China
3NCT00014794
(ClinicalTrials.gov)
April 200111/4/2001Positron Emission Tomography and Magnetic Resonance Imaging to Evaluate Synovial Blood Flow in Rheumatoid Arthritis PatientsH215O Positron Emission Tomography (PET) in the Assessment of Synovial Blood Flow in Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: 15-O labeled waterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompletedN/AN/ABoth10Phase 1United States

53. シェーグレン症候群


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.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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agemin
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size
PhaseCountries
1JPRN-UMIN000000997
2008/01/0128/01/2008The non-blind test crossover controlled trial how we used a physically unimpaired person volunteer about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrateThe non-blind test crossover controlled trial how we used a physically unimpaired person volunteer about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrate - A controlled trial about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrate Xerostomia due to Sjogren`s syndromeIt is a gargle with a test drug(Cevimeline hydrochloride hydrate 30mg+Hachiazule(TM)gargle 2g+distilled water 50cc)for two minutes. wash out, It is a gargle with false placebo1 (Cevimeline hydrochloride hydrate 9mg+Hachiazule(TM)gargle 2g+distilled water 50cc)for two minutes. wash out, It is a gargle with false placebo2 (Hachiazule(TM)gargle2g+distilled water 50cc)for two minutes.
It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with a test drug for two minutes.
It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with a test drug for two minutes. wash out, It is a gargle with false placebo1 for two minutes.
It is a gargle with a test drug for two minutes. wash out, It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with false placebo1 for two minutes.
It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with a test drug for two minutes. wash out,It is a gargle with false placebo2 for two minutes.
It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with a test drug for two minutes.
Department of Dentistry and Oral Surgery, Tochigi National HospitalNational Institute of Public HealthComplete: follow-up complete20years-old90years-oldMale and Female12Phase 1Japan

57. 特発性拡張型心筋症


臨床試験数 : 11 薬物数 : 23 - (DrugBank : 12) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 35
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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Inclusion_
agemin
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agemax
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PhaseCountries
1EUCTR2009-013112-12-GB
(EUCTR)
22/04/201017/03/2010Randomised Controlled Trial To Compare The effects of G-CSF(Granocyte™) And Autologous Bone Marrow Progenitor Cells On Quality Of Life And Left Ventricular Function In Patients with Idiopathic Dilated Cardiomyopathy - REGENERATE-DCMRandomised Controlled Trial To Compare The effects of G-CSF(Granocyte™) And Autologous Bone Marrow Progenitor Cells On Quality Of Life And Left Ventricular Function In Patients with Idiopathic Dilated Cardiomyopathy - REGENERATE-DCM Idiopathic Dilated Cardiomyopathy
Level: LLTClassification code 10056419Term: Dilated Cardiomyopathy
Trade Name: Granocyte Lenograstim
Product Name: GRANOCYTE - 34 million IU (Lenograstim rHuG-CSF)
Product Code: PL 12185/0002 & PL 12185/0005(WATER FOR INJECTION)
Barts & the London NHS TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom

63. 特発性血小板減少性紫斑病


臨床試験数 : 391 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1ChiCTR-INR-16009363
2016-10-132016-10-10'Yu Xue Qi Huo' theory based integrated Traditional Chinese and Western Medicine in the diagnosis and treatment of stratified relapsed and refractory primary immune thrombocytopenia'Yu Xue Qi Huo' theory based integrated Traditional Chinese and Western Medicine in the diagnosis and treatment of stratified relapsed and refractory primary immune thrombocytopenia Immune ThrombocytopeniaStudy Group A:Yangyin Traditional Chinese Medicine: brew the TCM granules in warm water, 1 pack bid p.o. 1 hour after meal for 6 months continuously;Study Group A:Cyclosporin A capsules: 5mg/kg/d p.o., adjusted according to the serum CsA concentration;Control group B:Traditional Chinese Medicine for control group;Control group B:Cyclosporin A capsules: 5mg/kg/d p.o., adjusted according to the serum CsA concentration ;Study Group C:Yangyin Traditional Chinese Medicine: brew the TCM granules in warm water, 1 pack bid p.o. 1 hour after meal for 6 months continuously ;Study Group C:rhTPO: 1ug/kg/d qd for 14 days continuously, ih, until platelet count reaches 100×10^9/L;Control Group D:Traditional Chinese Medicine for control group;Control Group D:rhTPO: 1ug/kg/d qd for 14 days continuously, ih, until platelet count reaches 100×10^9/L ;Ruijin Hospital affiliated to Shanghai Jiaotong University School of MedicineNULLRecruiting1875BothStudy Group A:55;Study Group A:55;Control group B:55;Control group B:55;Study Group C:45;Study Group C:45;Control Group D:45;Control Group D:45;China

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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Inclusion_
agemin
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PhaseCountries
1NCT00220766
(ClinicalTrials.gov)
August 200213/9/2005Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency PatientsIGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient PatientsImmunologic Deficiency Syndrome;Agammaglobulinemia;Severe Combined Immunodeficiency;Wiskott-Aldrich Syndrome;Common Variable ImmunodeficiencyDrug: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified;Drug: Dextrose, 5% in WaterGrifols Therapeutics Inc.NULLCompleted18 Years75 YearsBoth100Phase 3United States;Canada

67. 多発性嚢胞腎


臨床試験数 : 221 薬物数 : 212 - (DrugBank : 55) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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agemin
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agemax
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PhaseCountries
1NCT02933268
(ClinicalTrials.gov)
September 26, 201618/9/2016High Water Intake in Polycystic Kidney DiseaseDetermining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility TrialAutosomal Dominant Polycystic Kidney DiseaseDietary Supplement: High water intake;Other: Ad libitum water intakeCambridge University Hospitals NHS Foundation TrustPKD Charity;Addenbrookes Charitable Trust;British Renal Society & British Kidney Patient AssociationCompleted16 YearsN/AAll42N/AUnited Kingdom
2NCT02527863
(ClinicalTrials.gov)
February 201518/2/2015Effect of the Aquaretic Tolvaptan on Nitric Oxide SystemThe Effects of Tolvaptan on Renal Handling of Water and Sodium, Vasoactive Hormones and Central Hemodynamics During Baseline Conditions and After Inhibition of the Nitric Oxide System in Patients With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan;Drug: PlaceboRegional Hospital HolstebroAarhus University HospitalCompleted18 Years65 YearsAll18Phase 2Denmark
3EUCTR2014-001973-15-DK
(EUCTR)
18/11/201427/06/2014The effcts of tolvaptan on renal handling of water and salt, hormones in the blood at the circulation, during blocking of the nitric oxide (NO) system in patients with autosomal dominant polycystic kidney diseaseRenal Handling of Water and Sodium in Autosomal Dominant Polycystic Kidney Disease.The effects of tolvaptan on renal handling of water and sodium , vasoactive hormones and central hemodynamics during baseline conditions and after inhibition of the nitric oxide system in patients with autosomal dominant polycystic kidney disease - TOPO HyponatreamiaSIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) OverhydrationAutosomal dominant polycystic kidney disease
MedDRA version: 17.0;Level: LLT;Classification code 10021038;Term: Hyponatremia;System Organ Class: 100000004861
MedDRA version: 17.0;Classification code 10040626;Term: SIADH;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: Samsca
Product Name: Tolvaptan
Product Code: C03XA01
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
University Clinic in Nephrology and Hypertension, Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
Denmark

78. 下垂体前葉機能低下症


臨床試験数 : 492 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 100
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
Status
Inclusion_
agemin
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agemax
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size
PhaseCountries
1EUCTR2016-001145-11-IT
(EUCTR)
07/04/201710/01/2017A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) Growth hormone deficiency (GHD) in prepubertal children
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon hGH CT-301 (ACP-011) - 12,1mg
INN or Proposed INN: TransCon hGH (ACP-011)
Other descriptive name: Transiently PEGylated hGH prodrug
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection.
INN or Proposed INN: Somatropin
Other descriptive name: recombinant DNA-derived human growth hormone
Product Name: Sterile Water for Injection
Ascendis Pharma Endocrinology Division A/SNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000006533
2010/04/0130/10/2011Detecting sympathetic denervation and regional myocardial inflammation using 11C-hydroxyephedrine (HED) PET/CT and 18F-fluorodeoxyglucose (FDG) PET/CT and their relationship with arrhythmia in patients with cardiac involvement sarcoidosis and assessment of therapeutic effectsDetecting sympathetic denervation and regional myocardial inflammation using 11C-hydroxyephedrine (HED) PET/CT and 18F-fluorodeoxyglucose (FDG) PET/CT and their relationship with arrhythmia in patients with cardiac involvement sarcoidosis and assessment of therapeutic effects - Detecting sympathetic denervation and regional myocardial inflammation in patients with cardiac involvement sarcoidosis (CANVAS study) sarcoidosisAll patients with first diagnosis of cardiac sarcoidosis or without steroid treatment will undergo 11C HED PET/CT,18F FDG PET/CT, 15O-PET water, MIBG, 12 leads ECG, AECG , SAECG and echocardiogram (Echo) before starting corticosteroid therapy and repeat study at 4 weeks after starting corticosteroid therapy. These patients will also have reevaluation 6 to 12 month after the second evaluations.
Sarcoidosis without cardiac involvement will undergo steroid treatment will also repeat the same measurements 4 weeks after the treatment.
Cardiac sarcoidosis but will not have steroid treatment will also repeat the same measurements 12 months later. Sarcoidosis patients without steroid treatment will also repeat the same measurements 12 months later.
Cardiac sarcoidosis with steroid treatment.

Cardiac sarcoidosis without steroid treatment.
arcoidosis without cardiac involvement who will have steroid treatement.
Sarcoidosis without cardiac involvement who will not have steroid treatement.
Normal control.
Hokkaido University Graduate School of Medicine,NULLRecruitingNot applicableNot applicableMale and Female50Not applicableJapan

96. クローン病


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-002838-20-BE
(EUCTR)
09/12/201415/09/2014The effect of Vitamin D to prevent post-operative relapse of Crohn's DiseaseThe effect of Vitamin D3 to prevent post-operative relapse of Crohn’s Disease: a placebo-controlled randomized trial (DETECT) - DETECT Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: D-CURA
Product Name: D-Cura
INN or Proposed INN: Cholecalciferol
Other descriptive name: CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)
Academic Medical CenterNULLNot RecruitingFemale: yes
Male: yes
142Phase 3Belgium;Netherlands

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs052210199
22/03/202222/03/2022Comparison of GI tract pH and motility between patients with ulcerative colitis and healthy controlsComparison of total gastrointestinal pH and motility between healthy subjects and patients with ulcerative colitis using wireless motility/pH capsule Ulcerative colitisarm UC
arm Health control
In each case, the SmartPill motility capsule is orally taken with 50 ml of water. The temperature, pH and pressure of the entire digestive tract are measured in real time. Also, the transit time of each of the stomach, small intestine, and large intestine is calculated from the transit time of the capsule.
Nakamura ShiroHiguchi KazuhidePending>= 20age old<= 79age oldBoth25N/AJapan
2ChiCTR2200055616
2018-06-012022-01-14Air insufflation colonoscopy versus water-assisted colonoscopy in patients with ulcerative colitisFeasibility and effectiveness of water-assisted colonoscopy in patients with ulcerative colitis ulcerative colitisexperimental group 2: water immersion colonoscopy;experimental group 2:water exchange colonoscopy;control group:Air insufflation colonoscopy ;The Second Affiliated Hospital of Xi'an Jiaotong UniversityNULLRecruiting2367Bothexperimental group 2:70;experimental group 2:70;control group:70;China
3ChiCTR-TRC-13003530
2013-10-012013-08-08Effect of hydrogen rich water on ulcerative colitis: a randomized controlled trialEffect of hydrogen rich water on ulcerative colitis: a randomized controlled trial ulcerative colitisone:hydrogen rich water;two:pure water;411th Hospital of PLANULLCompleted1860Bothone:20;two:20;China
4NCT01783119
(ClinicalTrials.gov)
August 201231/1/2013Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative ColitisEffect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative ColitisUlcerative ColitisDietary Supplement: Aloe Barbadensis Miller;Dietary Supplement: placebo waterNational Institute of Medical Sciences and Nutrition, Salvador ZubiranNULLRecruiting18 Years59 YearsBoth60Phase 0Mexico
5JPRN-UMIN000008967
2009/01/0124/09/2012Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitisEfficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis - Efficacy of Polaprezinc enema in UC Ulcerative ColitisPolaprezinc group: Polaprezinc enema contained 150 mg of Polaprezinc suspension in tap water (total volume 100 mL) daily for one week

Placebo group: 100 mL tap water enema daily for one week
The Jikei University School of MedicineDivision of Gastroenterology and HepatologyNULLComplete: follow-up complete18years-oldNot applicableMale and Female30Not applicableJapan
6NCT00403923
(ClinicalTrials.gov)
April 200724/11/2006Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative ColitisA Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative ColitisLactose Intolerance;Ulcerative ColitisDietary Supplement: Lactose in waterUniversity Hospitals, LeicesterNULLCompleted18 YearsN/ABoth48United Kingdom

206. 脆弱X症候群


臨床試験数 : 108 薬物数 : 91 - (DrugBank : 36) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 77
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00362843
(ClinicalTrials.gov)
August 22, 20069/8/2006Protein Synthesis in the Brain of Patients With Fragile X SyndromePET Measurement of Regional Rates of Cerebral Protein Synthesis in Subjects With Fragile X SyndromeFragile X Syndrome;Healthy VolunteersDrug: [15-O]waterNational Institute of Mental Health (NIMH)NULLCompleted18 Years24 YearsMale147United States

226. 間質性膀胱炎(ハンナ型)


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000001253
2008/07/0116/07/2008A randomized trial to asses the effects of hydrogen-rich dissolution water in patients with interstitial cystitis Interstitial cystitisThe patients will be intervened with hydrogen dissolution water group (hydrogen group) 200ml every three times in a day in 2 months (56days).
After that, the patients in hydrogen dissolution water group will be transferred to the additional intervention term after the end of intervention.
And after that, the patients will be randomized to withdrawal terms for more 1 month with hydrogen dissolution water or with placebo water.

The patients will be intervened with normal water (placebo group) 200ml every three times in a day in 2 months (56days)
After that, the patients in placebo water group will be given hydrogen water for more 1 month.
Koushinkai HospitalNULLComplete: follow-up complete20years-old80years-oldMale and Female30Phase 2,3Japan

278. 巨大リンパ管奇形(頚部顔面病変)


臨床試験数 : 19 薬物数 : 22 - (DrugBank : 7) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 63
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs031180265
10/08/201613/03/2019Study of bleomycin and OK-432 combined scletotherapy for LMsClinical study of bleomycin and OK-432 combined local injection sclerotherapy for intractable lymphatic malformations Lymphangioma (lymphatic malformation, common or cystic lymphatic malformation), and other lymphatic
lymphangioma, lymphatic malformation,;D18.1
OK-432 and bleomycin slolution (0.05 kE / mL and 0.5 mg / mL, respectively) will be injected into the lesion with water-soluble contrast agent Maximum dose of bleomycin is 10 mg /dose and 5 mg/kgBW.Cumulative maximum dose in repeated treatment is 10 mg/kgBWFujino AkihiroNULLNot RecruitingNot applicableNot applicableBoth21N/AJapan

299. 嚢胞性線維症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-004033-25-ES
(EUCTR)
19/06/201731/03/2017Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosisEfect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial Cystic Fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10074550;Term: Preventive antimicrobial therapy in cystic fibrosis;System Organ Class: 100000004865
MedDRA version: 20.0;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Sodium bicarbonate
INN or Proposed INN: Sodium Bicarbonate
Other descriptive name: SODIUM BICARBONATE BP
Product Name: sodium chloride
INN or Proposed INN: Sodium chloride
Other descriptive name: SODIUM CHLORIDE
Product Name: sodium chloride
INN or Proposed INN: Sodium chloride
Other descriptive name: SODIUM CHLORIDE
Product Name: Water for injections
INN or Proposed INN: water for injections
Other descriptive name: WATER FOR INJECTIONS, EP
Fundació Parc TaulíNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Spain
2NCT01710644
(ClinicalTrials.gov)
May 201317/10/2012Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic FibrosisA Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients With Exocrine Pancreatic Insufficiency Due to Cystic FibrosisPancreatic Insufficiency;Cystic Fibrosis;Digestive System Diseases;Lung Diseases;Respiratory Tract DiseasesDrug: Burlulipase;Drug: Placebo (Caramel in sterile water)Nordmark Arzneimittel GmbH & Co. KGParexelCompleted12 YearsN/ABoth35Phase 1/Phase 2United States
3NCT01594827
(ClinicalTrials.gov)
October 20127/5/2012Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)Persistent MRSA Eradication Protocol (PMEP)Cystic FibrosisDrug: Inhaled Vancomycin;Drug: Placebo (Sterile Water);Drug: Rifampin;Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX);Drug: Doxycycline;Drug: Mupirocin Intranasal Creme;Drug: 4% chlorhexidine gluconate liquid skin cleanserJohns Hopkins UniversityCase Western Reserve University;Cystic Fibrosis FoundationCompleted12 YearsN/AAll29Phase 2United States
4EUCTR2006-006693-24-CZ
(EUCTR)
16/07/200809/05/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
INN or Proposed INN: Not available
Other descriptive name: 2622U90 Duramycin
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
5EUCTR2006-006693-24-DE
(EUCTR)
29/08/200729/05/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
INN or Proposed INN: Not available
Other descriptive name: 2622U90 Duramycin
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2;Phase 3France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden
6EUCTR2006-006693-24-FR
(EUCTR)
23/08/200716/05/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In Cystic Fibrosis chloride transport accross the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli 1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.Product Name: Moli 1901 (2622U90, duramycin)
Product Code: Moli 1901
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2;Phase 3France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden
7EUCTR2006-006693-24-SE
(EUCTR)
16/08/200702/07/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
8EUCTR2006-006693-24-HU
(EUCTR)
27/07/200718/06/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
9EUCTR2006-006693-24-AT
(EUCTR)
09/05/200711/01/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
10EUCTR2005-004344-30-HU
(EUCTR)
10/05/200623/12/2005An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung DiseaseAn Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance.Product Name: Moli1901 (2622U90, duramycin)
Product Code: EU Orphan Designation Number EU/3/02/120
Other descriptive name: Duramycin, 2622U90
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
18Hungary
11EUCTR2005-004344-30-AT
(EUCTR)
31/10/200526/09/2005An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung DiseaseAn Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance.Product Name: Moli1901 (2622U90, duramycin)
Product Code: EU Orphan Designation Number EU/3/02/120
Other descriptive name: Duramycin, 2622U90
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
18Hungary;Austria
12EUCTR2006-006693-24-PL
(EUCTR)
11/10/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
INN or Proposed INN: Not available
Other descriptive name: 2622U90 Duramycin
AOP Orphan Pharmaceuticals AGNULLNAFemale: yes
Male: yes
160Phase 2France;Hungary;Czech Republic;Spain;Poland;Austria;Germany;Italy;Sweden