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Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)

Primary Purpose

Bile Duct Diseases, Biliary Tract Diseases, Gallbladder Diseases

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IL-10
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bile Duct Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Adults weighing up to 125 kg who are undergoing ERCP for any of the following: Evaluate recurrent abdominal pain; Evaluate unexplained recurrent pancreatitis; Evaluate prior post-ERCP pancreatitis; Treatment of pancreatic disorders; Treatment of Common Bile Duct Stones (without jaundice) Exclusion criteria: Active (acute) pancreatitis; Chronic pancreatitis (moderate and severe cases); ERCP to perform a second procedure on biliary tract; Patients who previously had pancreatic sphincterotomy; Known or suspected pancreatic cancer or cancer of Papilla of Vater; Known or suspected other malignancy; History of, or current clotting or bleeding problems; Moderate and severe Anemia; Low platelet counts

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 20, 2002
    Last Updated
    October 30, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00040131
    Brief Title
    Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    December 2002 (Actual)
    Study Completion Date
    January 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if a single dose of IL-10 compared to placebo is safe and effective in reducing the incidence of post-ERCP acute pancreatitis for subjects with increased risk.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bile Duct Diseases, Biliary Tract Diseases, Gallbladder Diseases, Pancreatitis, Pancreatic Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    316 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    IL-10

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Adults weighing up to 125 kg who are undergoing ERCP for any of the following: Evaluate recurrent abdominal pain; Evaluate unexplained recurrent pancreatitis; Evaluate prior post-ERCP pancreatitis; Treatment of pancreatic disorders; Treatment of Common Bile Duct Stones (without jaundice) Exclusion criteria: Active (acute) pancreatitis; Chronic pancreatitis (moderate and severe cases); ERCP to perform a second procedure on biliary tract; Patients who previously had pancreatic sphincterotomy; Known or suspected pancreatic cancer or cancer of Papilla of Vater; Known or suspected other malignancy; History of, or current clotting or bleeding problems; Moderate and severe Anemia; Low platelet counts

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)

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