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

Tracking Information
First Received Date ^ICMJE	June 20, 2002
Last Updated Date	May 31, 2006
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00040131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention
Condition ^ICMJE	Bile Duct Diseases Biliary Tract Diseases Gallbladder Diseases Pancreatitis Pancreatic Diseases
Intervention ^ICMJE	Drug: IL-10
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	948
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00040131
Other Study ID Numbers ^ICMJE	P02580
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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