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Clinical trials for Pancreatin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    18 result(s) found for: Pancreatin. Displaying page 1 of 1.
    EudraCT Number: 2015-005491-20 Sponsor Protocol Number: 20151205 Start Date*: 2016-08-29
    Sponsor Name:Actavis Hungary Gyógyszermarketing és Kereskedelmi Korlátolt Felelősségű Társaság
    Full Title: The effect of pancreatic enzyme replacement therapy on glucose metabolism, nutritional parameters, incretin response and beta-cell function in patients with diabetes mellitus and exocrine pancreati...
    Medical condition: To study the patients with diabetes mellitus (type 1, 2 and 3c) and exocrine pancreatic insufficiency.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-002468-89 Sponsor Protocol Number: PANZ25STEA04-01 Start Date*: 2004-10-28
    Sponsor Name:Axcan Pharma S.A.
    Full Title: 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 I...
    Medical condition: 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 trea...
    Disease: Version SOC Term Classification Code Term Level
    7.0 10033622 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-000562-38 Sponsor Protocol Number: BCBe/03/Pan-CPI/002 Start Date*: 2010-04-20
    Sponsor Name:Berlin-Chemie AG
    Full Title: 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 WI...
    Medical condition: 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...
    Disease: Version SOC Term Classification Code Term Level
    7.0 10033628 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004940-31 Sponsor Protocol Number: 18122019 Start Date*: 2020-03-24
    Sponsor Name:Terese Katzenstein
    Full Title: Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial
    Medical condition: GI pains and fat malabsorption in cystic fibrosis patients with pancreas insufficiency
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10025479 Malabsorption syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-000736-24 Sponsor Protocol Number: BCBe/03/Pan-CPI/003 Start Date*: 2005-07-14
    Sponsor Name:Berlin-Chemie AG
    Full Title: 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...
    Medical condition: 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 t...
    Disease: Version SOC Term Classification Code Term Level
    7.0 10033628 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-004854-29 Sponsor Protocol Number: S245.4.008 Start Date*: 2007-09-21
    Sponsor Name:Abbott Products GmbH
    Full Title: One week double-blind, randomized, placebo-controlled, parallel-group, multi-center study with Creon® 25000 Minimicrospheres™ in subjects with pancreatic exocrine insufficiency after pancreatic sur...
    Medical condition: Pancreatic Exocrine Insufficiency
    Disease: Version SOC Term Classification Code Term Level
    8.1 10033628 Pancreatic insufficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) BG (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2013-002819-10 Sponsor Protocol Number: M13-621 Start Date*: 2013-11-29
    Sponsor Name:Abbott Laboratories GmbH
    Full Title: 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 Cy...
    Medical condition: Pancreatic exocrine Insufficiency due to Cystic Fibrosis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-006019-73 Sponsor Protocol Number: STH16190 Start Date*: 2012-11-14
    Sponsor Name:Sheffield Teaching Hospitals NHS Foundation Trust
    Full Title: Randomized, double blind, placebo-controlled trial of Creon in patients with low faecal pancreatic elastase
    Medical condition: Pancreatic Insufficiency
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-001438-34 Sponsor Protocol Number: 20-101 Start Date*: 2005-05-23
    Sponsor Name:McNeil Consumer and Specialty Pharmaceuticals
    Full Title: 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...
    Medical condition: Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000242-19 Sponsor Protocol Number: RHMGSU0241 Start Date*: 2018-04-13
    Sponsor Name:University Hospitals Southampton NHS Trust
    Full Title: Change in nutritional state and postoperative outcome following preoperative introduction of nutritional supplements and pancreatic enzymes in patients undergoing Whipple’s procedure for pancreatic...
    Medical condition: Patients undergoing Whipple’s procedure for pancreatic head tumours
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10033644 Pancreaticoduodenectomy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-001347-31 Sponsor Protocol Number: M13-954 Start Date*: 2013-11-12
    Sponsor Name:Abbott Laboratories GmbH
    Full Title: A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects with Diabetes Mellitus type 2
    Medical condition: Pancreatic exocrine insufficiency in diabetes type II
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005874-24 Sponsor Protocol Number: PEI004/2021 Start Date*: 2022-07-01
    Sponsor Name:Juan Enrique Domínguez Muñoz
    Full Title: Open label randomized, multicentre, controlled trial of pancreatic enzyme replacement therapy (PERT) for pancreatic exocrine insufficiency (PEI) in patients with unresectable pancreatic cancer
    Medical condition: pancreatic exocrine insufficiency (PEI) in patients with unresectable pancreatic cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-019267-11 Sponsor Protocol Number: MA-PA25CF10-01 Start Date*: Information not available in EudraCT
    Sponsor Name:Axcan Pharma Inc.
    Full Title: 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 WI...
    Medical condition: Correction of steathorrea associated with chronic exocrine pancreatic insufficiency in cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    13.1 10017947 - Gastrointestinal disorders 10033628 Pancreatic insufficiency PT
    13.1 10017947 - Gastrointestinal disorders 10041968 Steatorrhea LLT
    13.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-004519-35 Sponsor Protocol Number: PANC2002 Start Date*: 2015-01-09
    Sponsor Name:Abbott Laboratories GmbH
    Full Title: 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 Pancreat...
    Medical condition: Pancreatic exocrine Insufficiency due to Cystic Fibrosis
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) ES (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002739-17 Sponsor Protocol Number: AN-EPI3331 Start Date*: 2015-12-30
    Sponsor Name:ANTHERA Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancr...
    Medical condition: Pancreatic exocrine Insufficiency due to Cystic Fibrosis
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-012842-21 Sponsor Protocol Number: PR-005 Start Date*: 2010-09-20
    Sponsor Name:Aptalis Pharma US Inc.
    Full Title: Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficien...
    Medical condition: Exocrine pancreatic insufficiency associated with cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10015674 Exocrine pancreas conditions HLGT
    14.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed) BG (Completed) BE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2017-000571-85 Sponsor Protocol Number: AN-EPI3333 Start Date*: 2017-06-15
    Sponsor Name:ANTHERA Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancr...
    Medical condition: Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) ES (Prematurely Ended) PL (Prematurely Ended) GB (Prematurely Ended) LT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-001227-45 Sponsor Protocol Number: PHT/2017/20 Start Date*: 2017-06-12
    Sponsor Name:Portsmouth Hospitals NHS Trust
    Full Title: Comparison of ambulatory glucose profile prior to and during pancreatic enzyme replacement therapy in patients with diabetes and pancreatic exocrine insufficiency: a single-arm phase IV trial
    Medical condition: Type 1 diabetes and type 2 diabetes mellitus Pancreatic exocrine insufficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    20.1 10027433 - Metabolism and nutrition disorders 10045228 Type I diabetes mellitus LLT
    20.0 100000004856 10033628 Pancreatic insufficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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