24 completed, 4 recruiting, 3 unknown, 1 not yet recruiting. 33 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 33 | Completed 24, Recruiting 4, Unknown 3, Not yet recruiting 1, Terminated 1 |
| Phase 2 | 3 | Completed 2, Unknown 1 |
Follow Exocrine Pancreatic Insufficiency: new trials by email Literature Review of Exocrine Pancreatic Insufficiency trials Research Report on Exocrine Pancreatic Insufficiency
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis Dietary Supplement: Pancreatic enzyme preparation from microbial source that contains amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC)., Standard of care porcine pancreatic enzyme preparation: amylase (8000 U), lipase (25000 U), and protease (1000 U) - Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI) | Phase 3 | Recruiting | Asian Institute of Gastroenterology, India | 134 | 2026-10-12 | 2026-10-26 |
| Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis Pancreatic enzyme capsules, Placebo - Acute Necrotizing Pancreatitis, Pancreatic Exocrine Insufficiency | Phase 3 | Recruiting | Asian Institute of Gastroenterology, India | 140 | 2026-04-10 | 2026-05-05 |
| PERT in Acute Necrotizing Pancreatitis Pancreatic Enzyme Replacement Therapy, Placebo - Acute Pancreatitis Necrotizing, Nutrition Assessment | Phase 3 | Not yet recruiting | Asian Institute of Gastroenterology, India | 188 | 2025-10-01 | 2025-10-08 |
| Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients RELiZORB - Exocrine Pancreatic Insufficiency (EPI), Pancreatitis | Phase 3 | Recruiting | Massachusetts General Hospital | 60 | 2025-03-28 | 2026-05-15 |
| A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections Mavorixafor, Placebo - Neutropenia | Phase 3 | Recruiting | X4 Pharmaceuticals | 176 | 2024-06-06 | 2026-08-06 |
| Equivalence Study to Compare Two Strengths of Creon in China Creon® 25000, Creon® 10000 - Pancreatic Insufficiency | Phase 3 | Unknown | Abbott | 60 | 2017-08-31 | 2021-11-24 |
| RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Liprotamase, porcine PERT - Exocrine Pancreatic Insufficiency, Cystic Fibrosis | Phase 3 | Unknown | Anthera Pharmaceuticals | 140 | 2017-04-28 | 2018-03-08 |
| SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis Liprotamase Powder for Oral Solution - Exocrine Pancreatic Insufficiency, Cystic Fibrosis | Phase 3 | Completed | Anthera Pharmaceuticals | 15 | 2016-06-01 | 2018-05-11 |
| SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis Liprotamase, porcine (pig) PERT - Exocrine Pancreatic Insufficiency, Cystic Fibrosis | Phase 3 | Completed | Anthera Pharmaceuticals | 128 | 2015-06-01 | 2018-08-14 |
| Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis. EUR-1008 25,000 Units, Kreon 25,000 Units - Exocrine Pancreatic Insufficiency: Cystic Fibrosis | Phase 3 | Completed | Forest Laboratories | 96 | 2012-06-01 | 2014-03-14 |
| Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency Pancreatin - Pancreatic Exocrine Insufficiency | Phase 3 | Completed | Abbott Products | 40 | 2012-06-01 | 2014-07-15 |
| Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency Norzyme - Bergamo, Creon - Pancreatic Insufficiency | Phase 2 / Phase 3 | Unknown | Azidus Brasil | 25 | 2010-03-01 | 2010-10-28 |
| Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Pancrelipase Delayed Release - Cystic Fibrosis, Pancreatic Exocrine Insufficiency | Phase 3 | Completed | Solvay Pharmaceuticals | 19 | 2009-04-01 | 2010-11-08 |
| Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF) Ultrase® MT12 - Cystic Fibrosis, Pancreatic Insufficiency | Phase 3 | Completed | Forest Laboratories | 49 | 2009-04-01 | 2017-03-16 |
| A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency Pancrease MT 10.5, or MT 21, Placebo for Pancrease MT 10.5 or MT 21 - Exocrine Pancreatic Insufficiency, Steatorrhea | Phase 3 | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 40 | 2008-08-01 | 2014-05-09 |
| A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency SA-001 - Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy | Phase 3 | Completed | Abbott | 80 | 2008-07-01 | 2011-08-01 |
| Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF) Pancrelipase Delayed Release, Placebo Comparator - Cystic Fibrosis, Pancreatic Exocrine Insufficiency | Phase 3 | Completed | Solvay Pharmaceuticals | 17 | 2008-06-01 | 2010-06-02 |
| Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis Pancreatin, Placebo - Pancreatic Insufficiency | Phase 3 | Completed | Abbott Products | 62 | 2008-06-01 | 2011-08-18 |
| A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI) Placebo, EUR-1008 (APT-1008) High Dose, EUR-1008 (APT-1008) Low Dose - Chronic Pancreatitis, Exocrine Pancreatic Insufficiency | Phase 3 | Completed | Forest Laboratories | 82 | 2008-01-01 | 2014-03-12 |
| Phase III ALTU-135 CP Safety Trial Liprotamase - Exocrine Pancreatic Insufficiency | Phase 3 | Terminated | Anthera Pharmaceuticals | 39 | 2007-12-01 | 2014-10-24 |
Showing 20 of 33. Sign in to see all of them.
Cystic Fibrosis (17) · Pancreatitis, Chronic (7) · Steatorrhea (4) · Shwachman-Diamond Syndrome (3) · Anemia, Diamond-Blackfan (2) · Neutropenia, Severe Congenital, Autosomal Recessive 3 (2) · Pancreatitis (2) · Pancreatitis, Acute Necrotizing (2) · Abdominal Pain (1) · Anemia, Sickle Cell (1) · Autoimmune Diseases (1) · Barth Syndrome (1) · Bone Marrow Failure Disorders (1) · Cohen syndrome (1)
Digestive System Diseases (33) · Pancreatic Diseases (33) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (20) · Genetic Diseases, Inborn (20) · Infant, Newborn, Diseases (17) · Lung Diseases (17) · Respiratory Tract Diseases (17) · Pancreatitis (8) · Pathological Conditions, Signs and Symptoms (8) · Chronic Disease (7) · Disease Attributes (7) · Metabolic Diseases (7) · Nutritional and Metabolic Diseases (7) · Pathologic Processes (7) · Gastrointestinal Diseases (4)
liprotamase lipase (6) · Pancrelipase (5) · Antilymphocyte Serum (2) · Busulfan (2) · Pancreatin (2) · fludarabine phosphate (2) · Alemtuzumab (1) · Bone Marrow Transplantation (1) · Cyclophosphamide (1) · Granulocyte Colony-Stimulating Factor (1) · Lipase (1) · MT 21 (1) · Omeprazole (1) · Peptide Hydrolases (1) · Proton Pump Inhibitors (1)
Forest Laboratories (8) · Anthera Pharmaceuticals (6) · Solvay Pharmaceuticals (4) · Abbott (3) · Asian Institute of Gastroenterology, India (3) · Abbott Products (2) · Masonic Cancer Center, University of Minnesota (2) · Azidus Brasil (1) · Digestive Care, Inc. (1) · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (1) · Massachusetts General Hospital (1) · X4 Pharmaceuticals (1)
United States (23) · Poland (5) · Canada (4) · Hungary (4) · India (4) · Israel (4) · Spain (4) · Italy (3) · Ukraine (3) · United Kingdom (3) · Belgium (2) · Bulgaria (2) · Czechia (2) · France (2) · Germany (2)
Rupjyoti Talukdar, MD (3) · Monica Gangal (2) · Toshiaki Yamaguchi, BS Pharm (2) · Angela Smith, MD (1) · Casey M Luckhurst, MD (1) · Christopher Taylor, MD, PhD (1) · Guenter Krause, MD (1) · Michael W Konstan, MD (1) · Paul Orchard, MD (1) · Suntje Sander-Struckmeier, PhD (1)
PMID 32761612, PMID 19683970, PMID 19815466, PMID 20171415, PMID 21681115, PMID 25066363, PMID 27013382
2004 (1), 2009 (1), 2023 (1)