Pancreatitis Clinical Trial
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Merck Sharp & Dohme Corp. |
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