Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

This study has been terminated.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center Identifier:
First received: January 21, 2013
Last updated: February 25, 2015
Last verified: February 2015
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.

Condition Intervention Phase
Post-ERCP Acute Pancreatitis
Drug: Indomethacin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Resource links provided by NLM:

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Rate of post-ERCP pancreatitis in all patients [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Assess whether rectal indomethacin, compared to placebo, will lower the rate of post-ERCP pancreatitis in all patients

Secondary Outcome Measures:
  • Severity of post-ERCP pancreatitis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Assess the difference in severity of post-ERCP pancreatitis in patients who develop this condition

  • Post-fine needle aspiration pancreatitis in setting of concomitant ERCP/EUS [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Assess the rates of post-fine needle aspiration (FNA) pancreatitis in the setting of concomitant ERCP/endoscopic ultrasound examinations

Enrollment: 449
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indomethacin
Indomethacin 100 mg PR x 1 in peri-procedural period
Drug: Indomethacin
100 mg Indomethacin PR x 1
Placebo Comparator: Placebo
Placebo suppositories (#2)
Drug: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Scheduled for an ERCP at Dartmouth-Hitchcock
  2. Age greater than 18 years old
  3. Ability to provide written informed consent

Exclusion Criteria:

  1. Inability to provide written informed consent
  2. ERCP being performed for diagnosis and/or treatment of acute pancreatitis
  3. Current ongoing acute pancreatitis
  4. Previously documented allergy to NSAID
  5. Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)
  6. Pregnant or nursing mothers
  Contacts and Locations
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Please refer to this study by its identifier: NCT01774604

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Principal Investigator: John M Levenick, MD Dartmouth-Hitchcock Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT01774604     History of Changes
Other Study ID Numbers: CPHS#23749 
Study First Received: January 21, 2013
Last Updated: February 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Post ERCP acute pancreatitis
Post FNA acute pancreatitis

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 24, 2016