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Clinical trials for Pancrelipase

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   44346   clinical trials with a EudraCT protocol, of which   7374   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 ).  
     
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    4 result(s) found for: Pancrelipase. Displaying page 1 of 1.
    EudraCT Number: 2015-001219-11 Sponsor Protocol Number: PNCRLPCYS3001 Start Date*: 2015-03-31
    Sponsor Name:Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
    Full Title: 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-d...
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10011765 Cystic fibrosis pancreas LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2007-004004-12 Sponsor Protocol Number: S245.3.124 Start Date*: 2008-02-28
    Sponsor Name:Solvay Pharmaceuticals GmbH
    Full Title: 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
    Medical condition: 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 ...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009093 Chronic pancreatitis LLT
    9.1 10033596 Pancreatectomy LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2007-000342-12 Sponsor Protocol Number: VIO16EPI07-01 Start Date*: 2008-03-07
    Sponsor Name:Axcan Pharma Inc.
    Full Title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL, PLACEBO-CONTROLLED, PHASE III STUDY TO ASSESS THE SAFETY AND EFFICACY OF VIOKASE® 16 FOR THE CORRECTION OF STEATORRHEA IN PATIENTS WITH EXOCRINE P...
    Medical condition: Correction of steatorrhea (malabsorption of dietary fats) in patients with exocrine pancreatic insufficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10033628 Pancreatic insufficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (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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