299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
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 | NCT05069597 (ClinicalTrials.gov) | October 14, 2021 | 27/9/2021 | Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon | A Phase 4 Study to Assess Symptoms of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon® (Pancrelipase) With an Alternate Source of Active Pharmaceutical Ingredient | Cystic Fibrosis;Chronic Pancreatitis | Drug: CREON | AbbVie | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 4 | United States |
| 2 | NCT04315311 (ClinicalTrials.gov) | May 6, 2020 | 18/3/2020 | Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer | A Phase 4 Open-Label Single-Arm Study To Evaluate The Use Of CREON In Subjects With EPI Due To Etiologies Other Than Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer | Exocrine Pancreatic Insufficiency (EPI) | Drug: CREON | AbbVie | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 4 | United States |
| 3 | EUCTR2019-004940-31-DK (EUCTR) | 24/03/2020 | 24/03/2020 | Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial | Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial | GI pains and fat malabsorption in cysticfibrosis patients with pancreas insufficiency MedDRA version: 20.1;Level: LLT;Classification code 10025479;Term: Malabsorption syndrome;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Creon 10.000, hårde enterokapsler INN or Proposed INN: Pankreatin Other descriptive name: PANCREATIN Trade Name: Creon 25.000, hårde enterokapsler INN or Proposed INN: Pankreatin Other descriptive name: PANCREATIN Trade Name: Creon 40.000, hårde enterokapsler INN or Proposed INN: Pankreatin Other descriptive name: PANCREATIN | Terese Katzenstein | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Denmark | ||
| 4 | NCT03924947 (ClinicalTrials.gov) | November 6, 2019 | 18/4/2019 | A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | A Phase 4 Study to Compare US Marketed Creon Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site and With Drug Product Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Subjects With EPI Due to Cystic Fibrosis | Cystic Fibrosis | Drug: Pancrelipase | AbbVie | NULL | Completed | 12 Years | N/A | All | 36 | Phase 4 | United States;Spain |
| 5 | NCT02415959 (ClinicalTrials.gov) | March 2015 | 19/3/2015 | Efficacy and Safety Study 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 | Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Drug: Creon IR;Drug: Creon® (DR/GR) | Abbott | AbbVie;LKF Laboratorium für Klinische Forschung GmbH;Analytical Biochemical Laboratory;Parexel;Datamap;Linical Co., Ltd. | Completed | 12 Years | N/A | All | 70 | Phase 2 | Czech Republic;Hungary;Poland;Spain |
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | EUCTR2014-004519-35-ES (EUCTR) | 30/01/2015 | 04/12/2014 | 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: KREON de Liberación Inmediata INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATINA (Páncreas Polvo Trade Name: Kreon 25 000 Product Name: Kreon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATINA (Páncreas Polvo) | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | ||
| 9 | 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 | ||
| 10 | NCT02137382 (ClinicalTrials.gov) | January 2014 | 12/2/2014 | 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 | Drug: Creon®;Drug: Creon N | Abbott | NULL | Completed | 12 Years | N/A | All | 41 | Phase 3 | Hungary;Spain;Russian Federation |
| 11 | 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 | |||
| 12 | EUCTR2013-002819-10-HU (EUCTR) | 29/11/2013 | 14/10/2013 | 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] - Immune System Diseases [C20] | Product Name: CREON N 25000 INN or Proposed INN: not applicable Other descriptive name: PANCREATIN Trade Name: Creon 25000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Hungary;Spain;Russian Federation | |||
| 13 | NCT01652157 (ClinicalTrials.gov) | July 31, 2012 | 25/7/2012 | Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy) | A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients With Cystic Fibrosis Treated With Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors(The CF-FC Study) | Fibrosing Colonopathy | Biological: ULTRESA;Biological: PANCREAZE;Biological: CREON;Biological: ZENPEP;Biological: other non-sponsor pancreatic enzyme replacement therapy;Biological: PERTZYE;Other: No pancreatic enzyme replacement therapy | AbbVie | Cystic Fibrosis Foundation;Digestive Care, Inc.;Nestle Health Science;VIVUS, Inc. | Terminated | N/A | 99 Years | All | 17 | United States | |
| 14 | NCT01747330 (ClinicalTrials.gov) | June 2012 | 23/11/2012 | Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency | An Open Label, Multicenter Study Evaluating Safety and Tolerability of Creon Micro in Pediatric Subjects From at Least One Month to Less Than Four Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Pancreatic Exocrine Insufficiency | Drug: Pancreatin | Abbott Products | NULL | Completed | N/A | 4 Years | All | 40 | Phase 3 | Russian Federation |
| 15 | EUCTR2009-012842-21-IT (EUCTR) | 10/08/2010 | 23/08/2010 | A randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - ND | A randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - ND | exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) MedDRA version: 9.1;Level: HLGT;Classification code 10015674 MedDRA version: 9.1;Level: LLT;Classification code 10011762 | Trade Name: ZENPEP INN or Proposed INN: Multienzymes (lipase, protease etc.) Trade Name: CREON 10000 Capsules INN or Proposed INN: Multienzymes (lipase, protease etc.) | EURAND SPA | NULL | Not Recruiting | Female: yes Male: yes | 86 | Hungary;Bulgaria;Germany;United Kingdom;Italy | |||
| 16 | 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 |