Trial · NCT01774604
Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
NCT01774604, Phase 3, Terminated, Dartmouth-Hitchcock Medical Center; results first posted 2016-09-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis. Trials, record NCT01774604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01774604
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
- NCT number
- NCT01774604
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 449 participants, actual
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Conditions
- Post-ERCP Acute Pancreatitis
- Interventions
- Indomethacin, Placebo
- First posted
- 2013-01-24
- Last updated
- 2016-11-04
- Results first posted
- 2016-09-20
- Limitations and caveats
The study was terminated due to indomethacin's lack of efficacy after 449 patients had been enrolled. Thus the study may be underpowered to draw conclusions about the role of indomethacin in preventing post ERCP pancreatitis
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Developed Acute Pancreatitis | From randomization to 30 days after ERCP | Number of patients who developed pancreatitis following ERCP based on Atlanta Classification |
| Secondary | Number of Patients Who Developed Severe Pancreatitis | From randomization to 30 days after ERCP | Number of patients with severe acute pancreatitis based on the Atlanta Classification |
| Secondary | Number of Patients Who Developed Moderately Severe Pancreatitis | From randomization to 30 days after ERCP | Number of patients with moderately severe pancreatitis based on Atlanta Classification |
| Secondary | Number of Patients Who Developed Mild Pancreatitis | From randomization to 30 days after ERCP | Number of patient who developed mild acute pancreatitis based on the Atlanta Classification |
| Secondary | Number of Patients Who Developed Gastrointestinal Bleeding | From randomization to 30 days after ERCP | Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure |
| Secondary | Number of Patient Deaths | From randomization to 30 days after ERCP | Number of patients who died from any cause from the time of ERCP until 30 days post-procedure |
| Secondary | Number of Patients With 30 Days Hospital Re-admission | From randomization until 30 days after ERCP | Number of patients admitted to the hospital for any cause following ERCP |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Developed Acute Pancreatitis | From randomization to 30 days after ERCP | Patient who randomized into the study and received either rectal indomethacin or placebo | participants | NUMBER |
| SECONDARY | Number of Patients Who Developed Severe Pancreatitis | From randomization to 30 days after ERCP | Assess the number of patients who developed severe acute pancreatitis | participants | NUMBER |
| SECONDARY | Number of Patients Who Developed Moderately Severe Pancreatitis | From randomization to 30 days after ERCP | participants | NUMBER | |
| SECONDARY | Number of Patients Who Developed Mild Pancreatitis | From randomization to 30 days after ERCP | participants | NUMBER | |
| SECONDARY | Number of Patients Who Developed Gastrointestinal Bleeding | From randomization to 30 days after ERCP | participants | NUMBER | |
| SECONDARY | Number of Patient Deaths | From randomization to 30 days after ERCP | participants | NUMBER | |
| SECONDARY | Number of Patients With 30 Days Hospital Re-admission | From randomization until 30 days after ERCP | participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who Developed Acute Pancreatitis | Indomethacin | 16 | participants | ||
| Number of Patients Who Developed Acute Pancreatitis | Placebo | 11 | participants | ||
| Number of Patients Who Developed Severe Pancreatitis | Indomethacin | 0 | participants | ||
| Number of Patients Who Developed Severe Pancreatitis | Placebo | 1 | participants | ||
| Number of Patients Who Developed Moderately Severe Pancreatitis | Indomethacin | 0 | participants | ||
| Number of Patients Who Developed Moderately Severe Pancreatitis | Placebo | 1 | participants | ||
| Number of Patients Who Developed Mild Pancreatitis | Indomethacin | 16 | participants | ||
| Number of Patients Who Developed Mild Pancreatitis | Placebo | 9 | participants | ||
| Number of Patients Who Developed Gastrointestinal Bleeding | Indomethacin | 4 | participants | ||
| Number of Patients Who Developed Gastrointestinal Bleeding | Placebo | 6 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Indomethacin | 223 | |
| Overall Study | STARTED | Placebo | 226 | |
| Overall Study | COMPLETED | Indomethacin | 223 | |
| Overall Study | COMPLETED | Placebo | 226 | |
| Overall Study | NOT COMPLETED | Indomethacin | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events8
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 |
|---|---|---|---|---|---|---|
| other | Gastrointestinal Bleeding | Gastrointestinal disorders | Indomethacin | 4 | 223 | 4 |
| other | Gastrointestinal Bleeding | Gastrointestinal disorders | Placebo | 6 | 226 | 6 |
| serious | Severe Acute Pancreatitis Leading to Death | Gastrointestinal disorders | Indomethacin | 0 | 223 | 0 |
| serious | Severe Acute Pancreatitis Leading to Death | Gastrointestinal disorders | Placebo | 1 | 226 | 1 |
| serious | Secondary Bacterial Peritonitis due to Multifocal Hepatocellular Carcinoma Leading to Death | Gastrointestinal disorders | Indomethacin | 0 | 223 | 0 |
| serious | Secondary Bacterial Peritonitis due to Multifocal Hepatocellular Carcinoma Leading to Death | Gastrointestinal disorders | Placebo | 1 | 226 | 1 |
| serious | Aspiration Post-Procedure Leading to Death | Respiratory, thoracic and mediastinal disorders | Indomethacin | 0 | 223 | 0 |
| serious | Aspiration Post-Procedure Leading to Death | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 226 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Indomethacin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Indomethacin | 4 | 223 |
| Total, other adverse events | Placebo | 6 | 226 |
| Total, serious adverse events | Indomethacin | 0 | 223 |
| Total, serious adverse events | Placebo | 3 | 226 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26775631 | BACKGROUND |
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Indomethacin vs Placebo: Number of Patients Who Developed Moderately Severe Pancreatitis | Trial comparisons |
| Indomethacin vs Placebo: Number of Patient Deaths | Trial comparisons |
| Indomethacin vs Placebo: Number of Patients Who Developed Gastrointestinal Bleeding | Trial comparisons |
| Indomethacin vs Placebo: Number of Patients Who Developed Acute Pancreatitis | Trial comparisons |
| Indomethacin vs Placebo: Number of Patients Who Developed Severe Pancreatitis | Trial comparisons |
| Indomethacin vs Placebo: Number of Patients With 30 Days Hospital Re-admission | Trial comparisons |
| Indomethacin vs Placebo: Number of Patients Who Developed Mild 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/NCT01774604
GET https://conductscience.org/api/trials/v1/NCT01774604/registered