OCTREOTIDE ( DrugBank: Octreotide )


7 diseases
告示番号疾患名(ページ内リンク)臨床試験数
67多発性嚢胞腎7
75クッシング病2
84サルコイドーシス2
85特発性間質性肺炎1
89リンパ脈管筋腫症1
193プラダー・ウィリ症候群2
227オスラー病7

67. 多発性嚢胞腎


臨床試験数 : 216 薬物数 : 219 - (DrugBank : 50) / 標的遺伝子数 : 39 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03541447
(ClinicalTrials.gov)
December 12, 201817/5/2018Tolvaptan-Octreotide LAR Combination in ADPKDA Pilot, Phase II Study With a Prospective, Randomized, Cross-Over, Placebo-Controlled, Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or HyperfiltrationAutosomal Dominant Polycystic Kidney DiseaseDrug: Tolvaptan;Drug: Octreotide LAR;Other: PlaceboMario Negri Institute for Pharmacological ResearchOtsuka Pharmaceutical Italy S.r.l.Completed18 YearsN/AAll20Phase 2Italy
2EUCTR2017-004701-40-IT
(EUCTR)
06/08/201826/09/2019 STUDY TO ASSESS THE SHORT-TERM EFFECT OF THE ADMINISTRATION OF TOLVAPTAN AND OCTREOTIDE LAR COMPARED TO THE COMBINATION OF TOLVAPTAN AND PLACEBO IN PATIENTS AFFECTED BY ADPKD WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION A PILOT, PHASE II STUDY WITH A PROSPECTIVE, RANDOMIZED, CROSS-OVER, PLACEBO-CONTROLLED, DOUBLE-BLIND DESIGN TO ASSESS THE SHORT-TERM EFFECTS OF TOLVAPTAN PLUS PLACEBO VS TOLVAPTAN PLUS OCTREOTIDE LAR COMBINATION THERAPY IN ADPKD PATIENTS WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION - Tolvaptan-Octreotide combination in ADPKD Autosomal Dominant Policiytic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG)
Product Name: Jinarc
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG)
Product Name: Jinarc
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: JINARC - 30 MG +90 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 90 MG)
Product Name: Jinarc
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: SANDOSTATINA - LAR 20 MG/2.5 ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE FLACONE POLVERE + SIRINGA PRERIEMPITA 2.5 ML + 2 AGHI
Product Name: sandostatina LAR
Product Code: sandostatina
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRINULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noItaly
3NCT01377246
(ClinicalTrials.gov)
May 201120/6/2011Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal InsufficiencyA PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL TO ASSESS THE EFFECTS OF LONG-ACTING SOMATOSTATIN (OCTREOTIDE LAR) THERAPY ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE TO SEVERE RENAL INSUFFICIENCYAutosomal Dominant Polycystic Kidney DiseaseDrug: Octreotide-LAR;Other: Saline solution.Mario Negri Institute for Pharmacological ResearchNULLCompleted18 Years75 YearsAll100Phase 3Italy
4EUCTR2011-000138-12-IT
(EUCTR)
04/04/201128/12/2011A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2 Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: SANDOSTATINA LAR
INN or Proposed INN: Octreotide
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
80 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noItaly
5EUCTR2009-012376-27-IT
(EUCTR)
16/11/200930/11/2009EFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN IIEFFECTS OF LONG-ACTING SOMATOSTATIN ON DISEASE PROGRESSION IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE AND MODERATE/SEVERE RENAL INSUFFICIENCY(ALADIN II STUDY) - ALADIN II Polycystic Kidney
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant
Trade Name: SANDOSTATINA LAR
INN or Proposed INN: Octreotide
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot RecruitingFemale: yes
Male: yes
80Phase 3Italy
6NCT00426153
(ClinicalTrials.gov)
January 200722/1/2007Octreotide in Severe Polycystic Liver DiseasePilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver DiseasePolycystic Kidney, Autosomal Dominant;Polycystic Liver Disease;Hepatomegaly;Liver Diseases;Kidney, Polycystic;Abdominal PainDrug: Octreotide;Drug: PlaceboMayo ClinicNovartis;National Center for Research Resources (NCRR)Completed18 Years80 YearsAll42Phase 2/Phase 3United States
7EUCTR2005-005552-41-IT
(EUCTR)
20/02/200606/03/2007Effect of long-acting somatostatin on disease progression in nephropathy due to autosomal dominant polycystic disease a long-term three year follow-up study - ALADINEffect of long-acting somatostatin on disease progression in nephropathy due to autosomal dominant polycystic disease a long-term three year follow-up study - ALADIN Autosomal Dominant Polycystic Kidney Disease ADPKD
MedDRA version: 6.1;Level: SOC;Classification code 10038359
Trade Name: Sandostatina Lar IM Fl 20mg +2F
Product Name: octreotide
INN or Proposed INN: Octreotide
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noItaly

75. クッシング病


臨床試験数 : 203 薬物数 : 191 - (DrugBank : 51) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 128
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02019706
(ClinicalTrials.gov)
February 12, 201421/12/2013Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing SyndromeEvaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing SyndromeACTH;Cushing's SyndromeRadiation: DOTATATE PET-CT;Radiation: F-DOPA PET CT;Radiation: CT scan;Diagnostic Test: Routine MRI scan;Diagnostic Test: Gated MRI scan;Drug: 68Ga-DOTATATE;Drug: 18F-DOPAEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting18 Years80 YearsAll80Phase 2United States
2EUCTR2011-003264-77-NL
(EUCTR)
31/10/201107/09/2011A study with ketoconazole and octreotide combination therapy for treatment of Cushing’s disease.A prospective trial with ketoconazole and octreotide combination therapy for treatment of Cushing’s disease. - Octreotide and ketoconazole for Cushing's disease Cushing's disease (which is caused by an ACTH producing pituitary adenoma)
MedDRA version: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Octreotide
Product Name: Octreotide
Product Code: RVG 18236
Trade Name: Ketoconazole
Product Name: Ketoconazole
Product Code: RVG 08938
Trade Name: Cabergoline
Product Name: Cabergoline
Product Code: RVG 15375
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 227 - (DrugBank : 81) / 標的遺伝子数 : 82 - 標的パスウェイ数 : 167
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002160-14-NL
(EUCTR)
22/11/201625/10/2016Octreotide PET/CT scan for the imaging of disease activity in neurologic and cardiac sarcoidosis.68Ga-DOTA-NOC PET/CT for the imaging of disease activity in neurologic and cardiac sarcoidosis. - SCAN-GO Trial Sarcoidosis.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Gallium-68-DOTA-N-Octreotide
Product Code: Ga-68-DOTA-NOC
INN or Proposed INN: Ga-68-DOTA-NOC
Other descriptive name: DOTANOC
St. Antonius HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Netherlands
2EUCTR2013-005376-17-NL
(EUCTR)
20/06/201427/02/2014Sandostatin therapy in sarcoidosisSandostatin therapy in sarcoidosis - SST in SA Sarcoidosis
MedDRA version: 16.1;Level: HLGT;Classification code 10003816;Term: Autoimmune disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Sandostatin LAR
INN or Proposed INN: OCTREOTIDE
Other descriptive name: octreotide LAR / Sandostatin LAR (LAR=long acting release)
Erasmus Medical CenterNULLNot RecruitingFemale: yes
Male: yes
Netherlands

85. 特発性間質性肺炎


臨床試験数 : 598 薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00463983
(ClinicalTrials.gov)
October 200618/4/2007Treatment of Idiopathic Pulmonary Fibrosis With Long Acting OctreotidePhase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: octreotideInstitut National de la Santé Et de la Recherche Médicale, FranceNULLCompleted40 YearsN/ABoth25Phase 1/Phase 2France

89. リンパ脈管筋腫症


臨床試験数 : 39 薬物数 : 46 - (DrugBank : 20) / 標的遺伝子数 : 27 - 標的パスウェイ数 : 137
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00005906
(ClinicalTrials.gov)
June 20009/6/2000Treatment With Octreotide in Patients With LymphangioleiomyomatosisTreatment With Octreotide in Patients With LymphangioleiomyomatosisLymphangioleiomyomatosis;Lymphangiomyomas;Pleural Effusions;AscitesDrug: OctreotideNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted18 Years65 YearsFemale4Phase 2United States

193. プラダー・ウィリ症候群


臨床試験数 : 111 薬物数 : 120 - (DrugBank : 30) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 103
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00399893
(ClinicalTrials.gov)
December 200614/11/2006Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS)Investigation of the Developmental, Nutritional and Hormonal Regulation of Ghrelin in Children and Young Adults With Prader-Willi Syndrome (PWS): Octreotide Intervention Sub-studyPrader-Willi SyndromeDrug: Octreotide;Drug: PlaceboDuke UniversityNational Institutes of Health (NIH);National Center for Research Resources (NCRR);NovartisTerminated5 Years21 YearsAll5N/AUnited States
2NCT01613495
(ClinicalTrials.gov)
August 200513/4/2011Ghrelin Suppression by Octreotide in Prader-WilliGhrelin Suppression by Sandostatin LAR® Depot (Octreotide Acetate for Injectable Suspension) in Patients With Prader-Willi SyndromePrader Willis SyndromeDrug: Placebo;Drug: OctreotideOregon Health and Science UniversityNULLActive, not recruiting18 YearsN/AMale2N/ANULL

227. オスラー病


臨床試験数 : 54 薬物数 : 73 - (DrugBank : 21) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 136
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004179-11-IT
(EUCTR)
03/09/202117/08/2021Effectiveness of somatostatin analogues for GI bleeding in patients with hereditaryhemorrhagic telangiectasiaEffectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagictelangiectasia and symptomatic gastrointestinal bleeding, SAIPAN-trial: a multicentre,randomized, open-label, parallel-group, superiority trial. - SAIPAN study Hereditary hemorrhagic telangiectasia (HHT), also known as Osler–Weber–Rendu disease(in specific patients with gastrointestinal bleeding and transfusion dependency)
MedDRA version: 21.0;Level: PT;Classification code 10019883;Term: Hereditary haemorrhagic telangiectasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: octreotide a azione pronta 0,1 mg
Product Code: [OCTREOTIDE ACETATO]
INN or Proposed INN: OCTREOTIDE ACETATO
RADBOUD UNIVERSITY MEDICAL CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
38Phase 3France;Denmark;Netherlands;Germany;United Kingdom;Italy
2EUCTR2018-004179-11-FR
(EUCTR)
20/01/202126/11/2020The effectiveness of Octreotide in hereditary hemorrhagic telangiectasia (a.k.a. Rendu-Osler-Weber disease) patients who suffer from gastrointestinal bleeding.Effectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagic telangiectasia and symptomatic gastrointestinal bleeding, the SAIPAN-trial: a multicenter, randomized, open-label, parallelgroup, superiority trial. - SAIPAN-trial Hereditary hemorrhagic telangiectasia (HHT);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Octreotide
INN or Proposed INN: OCTREOTIDE
RadboudumcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
38Phase 3France;Germany;Netherlands
3EUCTR2018-004179-11-DE
(EUCTR)
12/08/202012/03/2020The effectiveness of Octreotide in hereditary hemorrhagic telangiectasia(a.k.a. Rendu-Osler-Weber disease) patients who suffer fromgastrointestinal bleeding.Effectiveness of Somatostatin Analogues in Patients with hereditaryhemorrhagic telangiectasia and symptomatic gastrointestinal bleeding,the SAIPAN-trial: a multicenter, randomized, open-label, parallel-group,superiority trial. - SAIPAN-trial Hereditary hemorrhagic telangiectasia (HHT), also known as Osler–Weber–Rendu disease (in specific patients with gastrointestinalbleedings);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Other descriptive name: OCTREOTIDE ACETATERadboudumcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
38Phase 3Italy;United Kingdom;Germany;Netherlands;France
4EUCTR2018-004179-11-NL
(EUCTR)
03/06/201914/05/2019The effectiveness of Octreotide in hereditary hemorrhagic telangiectasia (a.k.a. Rendu-Osler-Weber disease) patients who suffer from gastrointestinal bleeding.Effectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagic telangiectasia and symptomatic gastrointestinal bleeding, the SAIPAN-trial: a multicenter, randomized, open-label, parallelgroup, superiority trial. - SAIPAN-trial Hereditary hemorrhagic telangiectasia (HHT);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Octreotide
INN or Proposed INN: OCTREOTIDE
RadboudumcNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
38 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noNetherlands
5NCT02874326
(ClinicalTrials.gov)
October 201617/8/2016Octreotide in Patients With GI Bleeding Due to Rendu-Osler-WeberAn Uncontrolled, Pilot-study Assessing the Efficacy of Octreotide Long-acting Release to Decrease Transfusion Requirements and Endoscopy Frequency in Patients With Rendu-Osler-Weber and Gastrointestinal BleedingHereditary Hemorrhagic Telangiectasia;Gastrointestinal Hemorrhage;AnemiaDrug: Octreotide LARRadboud UniversitySt. Antonius HospitalUnknown status18 YearsN/AAll15Phase 2Netherlands
6EUCTR2016-001340-19-NL
(EUCTR)
21/07/201611/07/2016The effectiveness of the drug octreotide LAR to anemia in patients with gastrointestinal bleeding due to Rendu-Osler-Weber disease.An uncontrolled, pilot-study assessing the efficacy of octreotide LAR to decrease transfusion requirements and endoscopy frequency in patients with Rendu-Osler-Weber and gastrointestinal bleeding - ROW Patients with Rendu-Osler-Weber disease (which is also called: Hereditary hemorrhagic telangiectasia);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Sandostatin LAR 20 mg
Product Name: Sandostatin LAR
Product Code: RVG 18236
Radboud University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Netherlands
7NCT00004327
(ClinicalTrials.gov)
January 199518/10/1999Phase II Pilot Study of Octreotide, a Somatostatin Octapeptide Analog, for Gastrointestinal Hemorrhage in Hormone-Refractory Hereditary Hemorrhagic Telangiectasia and Senile EctasiaHereditary Hemorrhagic Telangiectasia;EctasiaDrug: octreotideNational Center for Research Resources (NCRR)Yale UniversityCompletedN/AN/ABoth8Phase 2NULL