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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:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00040131
First received: June 20, 2002
Last updated: May 31, 2006
Last verified: May 2006
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Estimated Enrollment: 948
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

ClinicalTrials.gov Identifier: NCT00040131     History of Changes
Other Study ID Numbers: P02580
Study First Received: June 20, 2002
Last Updated: May 31, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013