Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
This study is currently recruiting participants.
Verified May 2013 by Dartmouth-Hitchcock Medical Center
Sponsor:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01774604
First received: January 21, 2013
Last updated: May 9, 2013
Last verified: May 2013
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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:
Genetics Home Reference related topics:
hereditary pancreatitis
MedlinePlus related topics:
Pancreatitis
Drug Information available for:
Indomethacin
U.S. FDA Resources
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: | July 2015 |
| Estimated Primary Completion Date: | July 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:
- 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 NSAID
- 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
Contacts and Locations
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: | May 9, 2013 |
| 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 Pancreatic Diseases Digestive System Diseases Indomethacin Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs |
Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Cardiovascular Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013