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Rectal Indomethacin for Post-ERCP Pancreatitis
NCT00820612Phase 4
Key facts
- Status
- Terminated
- Start
- Jan 2009
- Primary completion
- Jul 2011
- Countries
- 1
- Sponsor
- University of Michigan
- Modality
- Small Molecules
- Drugs
- indomethacin
- Conditions
- post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP)
01
Overview
Phase 4, randomised, double-blind trial in post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) comparing Indomethacin with Placebo (2 arms). Primary endpoint: Post-ERCP Pancreatitis at 5 days. Started Jan 2009; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Indomethacin
Indomethacin 100 mg PR once
Placebo
Placebo suppositories
03
Who it enrols
Patients undergoing ERCP with high risk for post-ERCP pancreatitis (e.g., sphincter of Oddi dysfunction, history of PEP). Excludes active GI bleed, renal failure, and recent pancreatitis.
04
Endpoints
Primary
Post-ERCP Pancreatitis
Secondary
Moderate or Severe Post-ERCP Pancreatitis
Length of Hospital Stay
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