- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01774604
Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
September 28, 2016 updated by: Dartmouth-Hitchcock Medical Center
Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
449
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
-
-
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:
- Scheduled for an ERCP at Dartmouth-Hitchcock
- Age greater than 18 years old
- Ability to provide written informed consent
Exclusion Criteria:
- Inability to provide written informed consent
- ERCP being performed for diagnosis and/or treatment of acute pancreatitis
- Current ongoing acute pancreatitis
- Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
- Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)
- Pregnant or nursing mothers
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: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Indomethacin
Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period
|
100 mg Indomethacin PR x 1
|
Placebo Comparator: Placebo
Placebo suppositories (#2)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Who Developed Acute Pancreatitis
Time Frame: From randomization to 30 days after ERCP
|
Number of patients who developed pancreatitis following ERCP based on Atlanta Classification
|
From randomization to 30 days after ERCP
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Who Developed Severe Pancreatitis
Time Frame: From randomization to 30 days after ERCP
|
Number of patients with severe acute pancreatitis based on the Atlanta Classification
|
From randomization to 30 days after ERCP
|
Number of Patients Who Developed Moderately Severe Pancreatitis
Time Frame: From randomization to 30 days after ERCP
|
Number of patients with moderately severe pancreatitis based on Atlanta Classification
|
From randomization to 30 days after ERCP
|
Number of Patients Who Developed Mild Pancreatitis
Time Frame: From randomization to 30 days after ERCP
|
Number of patient who developed mild acute pancreatitis based on the Atlanta Classification
|
From randomization to 30 days after ERCP
|
Number of Patients Who Developed Gastrointestinal Bleeding
Time Frame: From randomization to 30 days after ERCP
|
Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure
|
From randomization to 30 days after ERCP
|
Number of Patient Deaths
Time Frame: From randomization to 30 days after ERCP
|
Number of patients who died from any cause from the time of ERCP until 30 days post-procedure
|
From randomization to 30 days after ERCP
|
Number of Patients With 30 Days Hospital Re-admission
Time Frame: From randomization until 30 days after ERCP
|
Number of patients admitted to the hospital for any cause following ERCP
|
From randomization until 30 days after ERCP
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John M Levenick, MD, Dartmouth-Hitchcock Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
January 21, 2013
First Submitted That Met QC Criteria
January 23, 2013
First Posted (Estimate)
January 24, 2013
Study Record Updates
Last Update Posted (Estimate)
November 4, 2016
Last Update Submitted That Met QC Criteria
September 28, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pancreatic Diseases
- Pancreatitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Reproductive Control Agents
- Gout Suppressants
- Tocolytic Agents
- Indomethacin
Other Study ID Numbers
- CPHS#23749
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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