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NCT00820612 · ClinicalTrials.gov registry record · Phase 4
Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients
A Phase 4 study, sponsored by University of Michigan.
- Terminated
- Registry status
- Phase 4
- Development phase
- 602
- Enrollment target
NCT00820612: Clinical Trial Phase 4 study, sponsored by University of Michigan.
NCT00820612 is a Phase 4 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 602 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00820612, a Phase 4 study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 602 participants
- Enrollment target
Study Summary
Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct. Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.
Primary Outcome
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.
Interventions
- DRUG Indomethacin
- OTHER Placebo suppositories
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2009-01 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
Why NCT00820612 stopped before completion
NCT00820612 is an interventional study that assigns participants to a tested intervention. The registered 602 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 2 interventions - of which Indomethacin is the first listed.
NCT00820612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00820612 about?
NCT00820612 is a clinical study titled "Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients". Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct. Preliminary data has shown that non-steroidal antiinflammatory drugs, when ad...
What is the current status of trial NCT00820612?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 602 participants. The study started on 2009-01. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00820612?
The interventions under investigation include: Indomethacin (DRUG), Placebo suppositories (OTHER).
Who is sponsoring clinical trial NCT00820612?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00820612's enrollment target sits among peer trials
602 137th of 2000 higher than 1,864 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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