Pancrelipase (DrugBank: Pancrelipase)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 298 | Hereditary pancreatitis | 7 |
| 299 | Cystic fibrosis | 13 |
| 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 | 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Chronic Pancreatitis | Pancreatitis | Drug: Pancrelipase;Drug: placebo | Dartmouth-Hitchcock Medical Center | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 2 | 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 | |
| 3 | 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 | |
| 4 | 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 |
| 5 | 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 |
| 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 | 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 | |||
| 7 | 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 |
| 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 | NCT03924947 (ClinicalTrials.gov) | October 23, 2019 | 18/4/2019 | A Study to Compare US Marketed Pancrelipase Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing 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, in Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Cystic Fibrosis | Cystic Fibrosis | Drug: Pancrelipase | AbbVie | NULL | Recruiting | 12 Years | N/A | All | 28 | Phase 4 | United States;Spain |
| 2 | NCT02372383 (ClinicalTrials.gov) | October 2014 | 20/6/2014 | Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis | Pharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus Controls | Cystic Fibrosis | Drug: Ethambutol;Drug: Rifampin;Drug: Azithromycin;Drug: Pancrelipase | University of Colorado, Denver | Cystic Fibrosis Foundation Therapeutics;Colorado Clinical & Translational Sciences Institute | Completed | 16 Years | 45 Years | Both | 32 | N/A | United States |
| 3 | NCT00775528 (ClinicalTrials.gov) | April 2009 | 17/10/2008 | Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | An Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Cystic Fibrosis;Pancreatic Exocrine Insufficiency | Drug: Pancrelipase Delayed Release | Solvay Pharmaceuticals | NULL | Completed | 1 Month | 6 Years | All | 19 | Phase 3 | United States |
| 4 | NCT00662675 (ClinicalTrials.gov) | August 2008 | 17/4/2008 | A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency | A Randomized Double-blind (Withdrawal) Phase 3 Study to Evaluate the Efficacy and Tolerability of Pancrelipase MT Capsules Compared With Placebo in the Treatment of Subjects With Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Steatorrhea;Malabsorption Syndromes;Cystic Fibrosis | Drug: Pancrease MT 10.5, or MT 21;Drug: Placebo for Pancrease MT 10.5 or MT 21 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NULL | Completed | 7 Years | 60 Years | All | 40 | Phase 3 | United States;Canada |
| 5 | 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 |
| 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 | NCT00690820 (ClinicalTrials.gov) | June 2008 | 3/6/2008 | Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF) | A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Cystic Fibrosis;Pancreatic Exocrine Insufficiency | Drug: Pancrelipase Delayed Release;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 7 Years | 11 Years | All | 17 | Phase 3 | United States |
| 7 | 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 | |||
| 8 | NCT00510484 (ClinicalTrials.gov) | November 2007 | 1/8/2007 | Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 24,000 Unit Capsules in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Cystic Fibrosis | Drug: Pancrelipase Delayed Release;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 12 Years | N/A | All | 35 | Phase 3 | United States;Hungary;Israel;South Africa;Spain |
| 9 | NCT00432861 (ClinicalTrials.gov) | January 2007 | 7/2/2007 | Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Crossover Study to Evaluate the Effectiveness and Safety of PANCRECARB® MS-16 (Pancrelipase) in Reducing Steatorrhea in Children and Adults With Cystic Fibrosis | Cystic Fibrosis;Pancreatic Insufficiency | Drug: PANCRECARB® (pancrelipase);Drug: Placebo | Digestive Care, Inc. | NULL | Completed | 7 Years | N/A | Both | 29 | Phase 3 | United States |
| 10 | NCT00217204 (ClinicalTrials.gov) | July 2005 | 13/9/2005 | An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption | A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Effectiveness of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers With Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption | Cystic Fibrosis;Steatorrhea | Drug: Pancrelipase microtablets | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. | NULL | Completed | 6 Months | 30 Months | Both | 18 | Phase 2 | Belgium;Netherlands |
| 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 |
| 11 | NCT00006063 (ClinicalTrials.gov) | July 1999 | 5/7/2000 | Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: pancrelipase with bicarbonate | National Center for Research Resources (NCRR) | Indiana University School of Medicine | Completed | N/A | N/A | Both | 24 | N/A | NULL | |
| 12 | EUCTR2015-001219-11-Outside-EU/EEA (EUCTR) | 31/03/2015 | A study of the efficacy and tolerability of pancrelipase microtablet (MT) capsules for the treatment of cystic fibrosis-dependent exocrine pancreatic insufficiency | A randomized double-blind (withdrawal) phase 3 study to evaluate the efficacy and tolerability of pancrelipase MT capsules compared with placebo in the treatment of subjects with cystic fibrosis-dependent exocrine pancreatic insufficiency | Cystic fibrosis MedDRA version: 17.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: PANCREASE MT Product Name: PANCREASE MT INN or Proposed INN: pancrelipase Other descriptive name: PANCRELIPASE AMYLASE | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. | NULL | NA | Female: yes Male: yes | 40 | Phase 3 | United States;Canada | |||
| 13 | EUCTR2005-001438-34-BE (EUCTR) | 15/07/2005 | A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption | A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption | Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption | Trade Name: Panzytrat® ok Product Name: Pancrelipase Microtablets Product Code: N/A INN or Proposed INN: Pancreatin | McNeil Consumer and Specialty Pharmaceuticals | NULL | NA | Female: yes Male: yes | 20 | Phase 2 | Belgium |