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NCT01912716 · ClinicalTrials.gov registry record · Phase 2
Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis
A Phase 2 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,037
- Enrollment target
NCT01912716: Completed Phase 2 study, sponsored by Indiana University.
NCT01912716 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 1,037 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (680% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01912716, a Phase 2 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,037 participants
- Enrollment target
Study Summary
It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of 100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk patients. However, the optimal dose required is not known. The purpose of this study is to determine whether a dose of 200 mg, administered as rectal suppositories, is more effective than the standard dose of 100 mg. An ERCP procedure is a scope procedure where a lighted tube with a camera is passed down the patient's throat and allows for evaluation of the bile duct and/or pancreatic duct. The most common side effect of this procedure is post-ERCP pancreatitis, or swelling of the pancreas. Some patients are at higher risk for this complication than others. Our hypothesis is to compare the efficacy of these two dose regimens (100 mg vs 200 mg) of prophylactic rectally-administered indomethacin on the frequency and severity of post-ERCP pancreatitis in high-risk patients.
Primary Outcome
Assessment of whether patients developed post-ERCP pancreatitis, defined as a new onset of pain (or worsening of existing pain) in the upper abdomen, an elevation in pancreatic enzymes of at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least two nights.
Interventions
- DRUG high dose indomethacin
- DRUG standard dose indomethacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,037 participants |
| Start Date | 2013-07 |
| Est. Completion | 2018-10 |
| Phase | Phase 2 |
What the finished NCT01912716 record still lists
NCT01912716 is an interventional study that assigns participants to a tested intervention. Its 1,037 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (680% higher).
The record links to 0 conditions, and to 2 interventions - of which high dose indomethacin is the first listed.
NCT01912716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01912716 about?
NCT01912716 is a clinical study titled "Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis". It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of 100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk patients. However, the opt...
What is the current status of trial NCT01912716?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,037 participants. The study started on 2013-07. Estimated completion is 2018-10.
What interventions are being tested in trial NCT01912716?
The interventions under investigation include: high dose indomethacin (DRUG), standard dose indomethacin (DRUG).
Who is sponsoring clinical trial NCT01912716?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01912716's enrollment target sits among peer trials
1,037 25th of 2000 higher than 1,976 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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