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.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: June 20, 2002
Last updated: May 21, 2013
Last verified: May 2013

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
Pancreatic Diseases
Drug: IL-10
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:

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

Estimated Enrollment: 948
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided Identifier: NCT00040131     History of Changes
Other Study ID Numbers: P02580
Study First Received: June 20, 2002
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bile Duct Diseases
Biliary Tract Diseases
Gallbladder Diseases
Pancreatic Diseases
Digestive System Diseases processed this record on October 20, 2014