- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00040131
Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)
October 30, 2015 updated by: Merck Sharp & Dohme LLC
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
316
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (ACTUAL)
December 1, 2002
Study Completion (ACTUAL)
January 1, 2003
Study Registration Dates
First Submitted
June 20, 2002
First Submitted That Met QC Criteria
June 20, 2002
First Posted (ESTIMATE)
June 21, 2002
Study Record Updates
Last Update Posted (ESTIMATE)
November 1, 2015
Last Update Submitted That Met QC Criteria
October 30, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P02580
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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