Kreon 25000 (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 298 | 遺伝性膵炎 | 1 |
| 299 | 嚢胞性線維症 | 6 |
| 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 | EUCTR2015-002570-20-ES (EUCTR) | 25/02/2016 | 18/04/2016 | Optimizing treatment of maldigestion in patients with chronic pancreatitis | Open label, randomized, crossover clinical trial to evaluate the efficacy of increasing doses of pancreatic enzymes against inhibition of acid gastric secretion in patients with exocrine pancreatic insufficiency secondary to chronic pancreatitis | Patients diagnosed of chronic pancreatitis with pancreatic exocrine insufficiency under pancreatic enzyme replacement therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25000 Product Name: Creon 25000 Product Code: PL 00512/0150 | Department of gastroenterology. University Hospital of Santiago | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain |
| 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 | EUCTR2013-002819-10-ES (EUCTR) | 26/12/2013 | 12/11/2013 | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: KREON N 25000 INN or Proposed INN: Not applicable Other descriptive name: PANCREATIN Trade Name: Kreon 25000 INN or Proposed INN: not assigned Other descriptive name: PANCREATINA | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Hungary;Spain;Russian Federation | |||
| 2 | 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 | |||
| 3 | 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 | ||
| 4 | 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 | |||
| 5 | 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 | |||
| 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 |
| 6 | 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 |