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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00040131
First Posted: June 21, 2002
Last Update Posted: November 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Bile Duct Diseases Biliary Tract Diseases Gallbladder Diseases Pancreatitis Pancreatic Diseases Drug: IL-10 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Enrollment: 316
Study Start Date: January 2002
Study Completion Date: January 2003
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00040131     History of Changes
Other Study ID Numbers: P02580
First Submitted: June 20, 2002
First Posted: June 21, 2002
Last Update Posted: November 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Gallbladder Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases