Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)

Pancreatitis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00040131
• Other study ID #: P02580
• Status: Terminated
• Phase: Phase 2
• First received: June 20, 2002
• Last updated: October 30, 2015
• Start date: January 2002
• Est. completion date: January 2003

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 316
• Est. completion date: January 2003
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bile Duct Diseases
• Biliary Tract Diseases
• Gallbladder Diseases
• Pancreatic Diseases
• Pancreatitis

Intervention

Drug:
• IL-10

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.