298. 遺伝性膵炎 Hereditary pancreatitis Clinical trials / Disease details
臨床試験数 : 98 / 薬物数 : 180 - (DrugBank : 57) / 標的遺伝子数 : 53 - 標的パスウェイ数 : 142
| 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 | NCT05261997 (ClinicalTrials.gov) | March 2022 | 24/11/2021 | Endotherapy for Painless Chronic Pancreatitis | Effect of Endotherapy on the Progression of Chronic Pancreatitis in Painless Patients | Pancreatitis, Chronic;Exocrine Pancreatic Insufficiency;Abdominal Pain;Cholangiopancreatography, Endoscopic Retrograde | Procedure: extracorporeal shock wave lithotripsy and endoscopic drainage of the main pancreatic duct;Drug: pancreatic enzyme(Pancreatin Enteric-coated Capsules or Oryz-Aspergillus Enzyme and Pancreatin Table), antidiabetic medicine(Acarbose Tablets, Glucophage, Glimepirde Tablets) | Changhai Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 60 | N/A | China |
| 2 | 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 |
| 3 | NCT02706236 (ClinicalTrials.gov) | April 2016 | 27/2/2016 | Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis | A Single-Center Prospective Randomized Placebo Controlled Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis | Pancreatitis | Drug: Pancrelipase;Drug: placebo | Dartmouth-Hitchcock Medical Center | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 4 | JPRN-UMIN000013182 | 2013/10/16 | 18/02/2014 | Efficacy of the pancrelipase for early chronic pancreatitis | early chronic pancreatitis | Pancrelipase no treatment | Fukushima Medical University Aizu Medical Center | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 60 | Not selected | Japan | |
| 5 | JPRN-UMIN000009547 | 2012/08/01 | 01/01/2013 | Prospectivestudy on the treatment effect of pancrelipase on chronic pancreatitis patient's alubumin concentration | Chronic pancreatitis | 600mg of Pancrelipase (granules or capsels) to be taken three times a day (1800mg /day) after meals for 4 weeks. | Department of Internal Medicine Second Teaching Hospital Fujita Health University School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 83 | Not applicable | Japan | |
| 6 | EUCTR2005-000562-38-DE (EUCTR) | 20/04/2010 | 29/09/2005 | RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A GASTRO-RESISTANT FILM-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 002 | RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A GASTRO-RESISTANT FILM-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 002 | The purpose of this trial is to evaluate the clinical efficacy and safety of a gastro-resistant film-coated tablet in comparison to placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis MedDRA version: 7.0;Level: LLT;Classification code 10033628 | Trade Name: Mezym F Product Name: Mezym F Product Code: Pancreatin INN or Proposed INN: Pancreatin | Berlin-Chemie AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Germany | ||
| 7 | NCT01142128 (ClinicalTrials.gov) | February 2009 | 9/6/2010 | Viokase 16, Viokase16 Plus Nexium and Nexium Alone | A Randomized, Single Site, Double Blind, Fixed Dose, Cross Over Study of Viokase 16, Viokase16 Plus Nexium and Nexium Alone in the Reduction of Abdominal Pain in Patients With Chronic Pancreatitis | Chronic Pancreatitis | Drug: Nexium (esomeprazole magnesium);Drug: Placebo to Nexium;Drug: Viokase 16 (pancrelipase) + Nexium;Drug: Viokase 16 + placebo to Nexium | University of Florida | AstraZeneca | Terminated | 18 Years | 75 Years | All | 12 | Phase 1 | United States |
| 8 | NCT00744250 (ClinicalTrials.gov) | August 2008 | 28/8/2008 | Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control | Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Chronic Pancreatitis;Cystic Fibrosis | Drug: Pancrelipase | Digestive Care, Inc. | University of North Carolina, Chapel Hill | Terminated | 18 Years | N/A | Both | 3 | Phase 4 | United States |
| 9 | NCT00705978 (ClinicalTrials.gov) | June 2008 | 26/6/2008 | Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis | A One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Followed by an Open-Label Long-Term Extension | Pancreatic Insufficiency | Drug: Pancreatin;Drug: Placebo | Abbott Products | Quintiles, Datamap | Completed | 18 Years | N/A | Both | 62 | Phase 3 | India |
| 10 | 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 | |||
| 11 | NCT00414908 (ClinicalTrials.gov) | October 2007 | 21/12/2006 | A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy | A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy | Chronic Pancreatitis;Pancreatectomy;Pancreatic Exocrine Insufficiency | Drug: Pancrelipase delayed release capsule;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 52 | Phase 3 | United States;Bulgaria;Poland;Puerto Rico;Russian Federation;Serbia;South Africa;Ukraine;Former Serbia and Montenegro |
| 12 | EUCTR2005-000736-24-DE (EUCTR) | 14/07/2005 | 13/05/2005 | RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AN ENTERIC-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF 13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 003 | RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AN ENTERIC-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF 13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 003 | The purpose of this trial is to evaluate the clinical efficacy and safety of an enteric-coated pancreatin tablet in comparison to placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis. MedDRA version: 7.0;Level: LLT;Classification code 10033628 | Trade Name: Helopanflat Mono® Product Name: Helopanflat Mono® Product Code: Pancreatin INN or Proposed INN: Pancreatin | Berlin-Chemie AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Germany | ||
| 13 | EUCTR2004-002468-89-DE (EUCTR) | 28/10/2004 | 23/09/2004 | A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PANCREATIN VS. PLACEBO FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY - Pancreatin vs. Placebo in Patients with Pancreatic Exocrine Insufficiency | A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PANCREATIN VS. PLACEBO FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY - Pancreatin vs. Placebo in Patients with Pancreatic Exocrine Insufficiency | The purpose of this clinical trial is to evaluate the clinical efficacy and safety of a capsule containing enteric-coated porcine pancreatin microfilm tablets in comparison with placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis. MedDRA version: 7.0;Level: LLT;Classification code 10033622 | Trade Name: Panzytrat 25.000 Product Name: Panzytrat 25.000 Product Code: Pancreatin INN or Proposed INN: Pancreatin | Axcan Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Germany |