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Safety and efficacy study of IL-10 (Tenovil TM) in the prevention of Post-ERCP Acute Pancreatitis



Safety and efficacy study of IL-10 (Tenovil TM) in the prevention of Post-ERCP Acute Pancreatitis

For Condition: Pancreatitis,Bile Duct Diseases,Biliary Tract Diseases,Gallbladder Diseases,Pancreatic Diseases
Status: Terminated
Sponsor(s): Schering-Plough ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 948

Location and Contact Information:

Columbia Presbyterian Medical Center
New York City,  New York, 
United States
 

St. Louis University - Div. of GI/Hep.
St. Louis,  Missouri, 
United States
 

Richmond GI Research Group
Richmond,  Virginia, 
United States
 

Beth Israel North
New York City,  New York, 
United States
 

University of Colorado Hospital
Aurora,  Colorado, 
United States
 

Queens Medical Center
Nottingham,  , 
United Kingdom
 

Gastroenterology Consultants
Milwaukee,  Wisconsin, 
United States
 

Brigham & Women's Hospital
Boston,  Massachusetts, 
United States
 

Cleveland Clinic Foundation
Cleveland,  Ohio, 
United States
 

Penn State University
Hershey,  Pennsylvania, 
United States
 

Rocky Mountain Gastroenterology Associates
Lakewood,  Colorado, 
United States
 

Digestive Disorders Associates
Annapolis,  Maryland, 
United States
 

University of Pittsburgh Medical Center
Pittsburgh,  Pennsylvania, 
United States
 

UZ Gasthuisberg
Leuven,  , 
Belgium
 

Ospedale San Raffaele
Milan,  , 
Italy
 

Maimonides Medical Center
Brooklyn,  New York, 
United States
 

University of Kentucky
Lexington,  Kentucky, 
United States
 

Digestive & Liver Disease
New York City,  New York, 
United States
 

Virginia Mason Medical Center
Seattle,  Washington, 
United States
 

Univ. of Clinic of Vienna
Vienna,  , 
Austria
 

Gastroenterology Consultants
Milwaukee,  Wisconsin, 
United States
 

Division of Gastroenterology
St. Louis,  Missouri, 
United States
 

Hennepin County Medical Center
Minneapolis,  Minnesota, 
United States
 

Mayo Clinic El
Rochester,  Minnesota, 
United States
 

Interventional Endoscopy Services
San Francisco,  California, 
United States
 

Digestive Health Physician
Cheektowaga,  New York, 
United States
 

Hospital Erasme ULB
Bruelles,  , 
Belgium
 

Cedars Sinai Medical Center - G.I. Department
Los Angeles,  California, 
United States
 

Division of Gastroenterology
Pittsburgh,  Pennsylvania, 
United States
 

Weill Medical College of Cornell University
New York City,  New York, 
United States
 

Oakland Gastroenterology Associates
Southfield,  Michigan, 
United States
 

University of Florida
Gainesville,  Florida, 
United States
 

University of Iowa - Dept. of Internal Medicine
Iowa City,  Iowa, 
United States
 

Duke University Medical School
Durham,  North Carolina, 
United States
 

Outpatient Pavilion
Aurora,  Colorado, 
United States
 

Policlinico Gemelli
Rome,  , 
Italy
 

Indiana University Medical Center
Indianapolis,  Indiana, 
United States
 

Clinica Santa Maria
Santiago,  , 
Chile
 

A.P.H. Paris, Hopital Bicetre
Bicetre,  , 
France
 

Hospices Civils de Lyon, Hopital Edouard Herriot
Lyon,  , 
France
 


Additional Information:
Study ID Numbers:
  P02580; 
Study Start Date: 
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040131

Other Bile Duct Diseases Studies:
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2. Safety and efficacy study of IL-10 (Tenovil TM) in the prevention of Post-ERCP Acute Pancreatitis

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