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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00040131
Other study ID # P02580
Secondary ID
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


Intervention

Drug:
IL-10


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.
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