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.

First Received: June 20, 2002 Last Updated: May 31, 2006 History of Changes

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00040131

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 II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Bile Duct Diseases Gallbladder Diseases Pancreatic Diseases

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

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

Additional relevant MeSH terms:

Gallbladder Diseases
Digestive System Diseases
Bile Duct Diseases

Biliary Tract Diseases
Pancreatic Diseases
Pancreatitis

ClinicalTrials.gov processed this record on November 03, 2009