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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.
Study NCT00040131   Information provided by Schering-Plough
First Received: June 20, 2002   Last Updated: May 31, 2006   History of Changes

June 20, 2002
May 31, 2006
 
 
 
 
Complete list of historical versions of study NCT00040131 on ClinicalTrials.gov Archive Site
 
 
 
Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)
 

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.

 
Phase II
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
  • Bile Duct Diseases
  • Biliary Tract Diseases
  • Gallbladder Diseases
  • Pancreatitis
  • Pancreatic Diseases
Drug: IL-10
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
948
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00040131
 
P02580
Schering-Plough
 
 
Schering-Plough
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP