Pancreas Powder ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 299 | 嚢胞性線維症 | 10 |
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. | 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 | EUCTR2014-004519-35-GB (EUCTR) | 23/02/2015 | 08/12/2014 | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CREON IR INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATIN (PAncreas Powder) Trade Name: Kreon 25 000 Product Name: Creon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN (Pancreas Powder) | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | ||
| 2 | EUCTR2014-004519-35-CZ (EUCTR) | 18/02/2015 | 19/11/2014 | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CREON IR INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATIN (PAncreas Powder) Trade Name: Kreon 25 000 Product Name: Creon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN (Pancreas Powder) | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Hungary;Czech Republic;Spain;United Kingdom | ||
| 3 | EUCTR2014-004519-35-HU (EUCTR) | 09/01/2015 | 12/11/2014 | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CREON IR INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATIN (Pancreas Powder) Trade Name: Kreon 25 000 Product Name: Creon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN (Pancreas Powder) | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | ||
| 4 | EUCTR2009-012842-21-HU (EUCTR) | 27/06/2013 | 10/05/2013 | Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Hungary;Bulgaria;Germany;Italy;United Kingdom | |||
| 5 | EUCTR2009-012842-21-BE (EUCTR) | 19/11/2012 | 14/05/2012 | Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREASLIPASE | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 3 | Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2009-012842-21-BG (EUCTR) | 24/02/2011 | 28/09/2010 | Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | France;Hungary;Belgium;Spain;Poland;Ireland;Romania;Bulgaria;Germany;United Kingdom;Italy | |||
| 7 | EUCTR2009-012842-21-DE (EUCTR) | 13/01/2011 | 13/07/2010 | Treatment of Exocrine Pancreatic Insufficiency in Subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Hungary;Bulgaria;Germany;Italy;United Kingdom | |||
| 8 | EUCTR2009-012842-21-GB (EUCTR) | 20/09/2010 | 17/06/2010 | Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREASLIPASE | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom | ||
| 9 | EUCTR2007-004004-12-BG (EUCTR) | 28/02/2008 | 05/02/2008 | A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY | A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY | Pancreatic enzyme replacement therapy is the cornerstone of nutritional management of pancreatic exocrine insufficiency (PEI) due to e.g. cystic fibrosis, chronic pancreatitis, partial or complete pancreatectomy or gastrectomy. Without pancreatic enzyme replacement the patients suffer from severe symptoms of maldigestion as manifested by steatorrhea, abdominal pain, body weight loss etc. MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis MedDRA version: 9.1;Classification code 10033596;Term: Pancreatectomy | Trade Name: Creon 10000 Product Name: Pancrelipase Delayed Release Capsule Other descriptive name: Pancrelipase/Pancreas Powder Trade Name: Creon 25000 Product Name: Pancrelipase Delayed Release Capsule Other descriptive name: Pancrelipase/Pancreas Powder | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 52 | Bulgaria | |||
| 10 | EUCTR2010-019267-11-DE (EUCTR) | 19/10/2010 | AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI) | AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI) | Correction of steathorrea associated with chronic exocrine pancreatic insufficiency in cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1;Level: LLT;Classification code 10041968;Term: Steatorrhea;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: PANZYTRAT 25000 Product Name: PANZYTRAT 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: KREON 25000 Product Name: KREON 25000 Other descriptive name: PANCREATIN | Axcan Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 68 | Germany |