Trial · NCT00820612
Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients
NCT00820612, Phase 4, Terminated, University of Michigan; results first posted 2013-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients. Trials, record NCT00820612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00820612
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients
- NCT number
- NCT00820612
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 602 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Post-ERCP Pancreatitis
- Interventions
- Indomethacin, Placebo suppositories
- First posted
- 2009-01-12
- Last updated
- 2013-02-28
- Results first posted
- 2013-02-12
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-ERCP Pancreatitis | 5 days | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Post-ERCP Pancreatitis | 5 days | 100% completed follow-up | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Post-ERCP Pancreatitis | Placebo | 52 | 37.6 | participants | |
| Post-ERCP Pancreatitis | Indomethacin | 27 | 28.9 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 307 | |
| Overall Study | STARTED | Indomethacin | 295 | |
| Overall Study | COMPLETED | Placebo | 307 | |
| Overall Study | COMPLETED | Indomethacin | 295 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Indomethacin | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | GI bleeding | Gastrointestinal disorders | Placebo | 7 | 307 | 7 |
| serious | GI bleeding | Gastrointestinal disorders | Indomethacin | 4 | 295 | 4 |
| serious | Renal failure | Renal and urinary disorders | Placebo | 2 | 307 | 2 |
| serious | Renal failure | Renal and urinary disorders | Indomethacin | 0 | 295 | 0 |
| serious | Post-ercp pancreatitis | Gastrointestinal disorders | Placebo | 52 | 307 | 52 |
| serious | Post-ercp pancreatitis | Gastrointestinal disorders | Indomethacin | 27 | 295 | 27 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Indomethacin | ||
| Total, other adverse events | Placebo | 0 | 307 |
| Total, other adverse events | Indomethacin | 0 | 295 |
| Total, serious adverse events | Placebo | 61 | 307 |
| Total, serious adverse events | Indomethacin | 31 | 295 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22494121 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Indomethacin vs Placebo: Post-ERCP Pancreatitis | Trial comparisons |
| Indomethacin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00820612
GET https://conductscience.org/api/trials/v1/NCT00820612/registered