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

Phase 2TerminatedNCT00040131

Merck Sharp & Dohme LLC316 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

316

Conditions

Bile Duct Diseases Biliary Tract Diseases Gallbladder Diseases Pancreatitis Pancreatic Diseases

Interventions

IL-10DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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