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Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01774604
First received: January 21, 2013
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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


Estimated Enrollment: 1398
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774604

Contacts
Contact: John M Levenick, MD 6036508150 john.m.levenick@hitchcock.org
Contact: Timothy B Gardner, MD 6036508150 timothy.b.gardner@hitchcock.org

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: John M Levenick, MD    603-650-8150    john.m.levenick@hitchcock.org   
Contact: Timothy B Gardner, MD    6036508150    timothy.b.gardner@hitchcock.org   
Principal Investigator: John M Levenick, MD         
Principal Investigator: Timothy B Gardner, MD         
Principal Investigator: Stuart R Gordon, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: John M Levenick, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01774604     History of Changes
Other Study ID Numbers: CPHS#23749
Study First Received: January 21, 2013
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases
Indomethacin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 24, 2014