Trial · NCT02692391
A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis
NCT02692391, Phase 3, Completed, University of Pittsburgh; results first posted 2021-04-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis. Trials, record NCT02692391. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02692391
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis
- NCT number
- NCT02692391
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 42 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Acute Pancreatitis
- Interventions
- Indomethacin, Placebo
- First posted
- 2016-02-26
- Last updated
- 2021-04-22
- Results first posted
- 2021-04-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Systemic Inflammatory Response Syndrome (SIRS) Score | The change in the SIRS score (48 hours - baseline) | SIRS is a simple clinical score, ranging from 0-4, that utilizes objective, routine clinical parameters (body temperature, heart rate, respiratory rate or arterial carbon dioxide tension and white blood count) that directly reflect the underlying inflammatory response. A lower change in SIRS score (negative number) indicates a better outcome (less inflammation). |
| Primary | C-Reactive Protein (CRP) Levels. | 48 hours | CRP levels at 48 hours after enrollment minus CRP levels at enrollment (baseline). A negative number indicates a better outcome (less inflammation). |
| Secondary | Number of Participants Who Development of Organ Failure | 7 days | Including respiratory, renal and cardiovascular failures defined as modified Marshal score of equal and greater than 2. The minimum and maximum values in the modified Marshal score for each organ failure range from 0 to 4 with a higher value representing worse outcomes. |
| Secondary | Mortality | 1 month | Enrolled subjects that died. A death indicates a worse outcome. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Systemic Inflammatory Response Syndrome (SIRS) Score | The change in the SIRS score (48 hours - baseline) | score on a scale | MEAN | |
| PRIMARY | C-Reactive Protein (CRP) Levels. | 48 hours | mg/dL | MEAN | |
| SECONDARY | Number of Participants Who Development of Organ Failure | 7 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mortality | 1 month | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Systemic Inflammatory Response Syndrome (SIRS) Score | Placebo | -0.96 | Standard Deviation 0.81 | score on a scale | |
| Systemic Inflammatory Response Syndrome (SIRS) Score | Indomethacin Suppository | -1 | Standard Deviation 1.24 | score on a scale | |
| C-Reactive Protein (CRP) Levels. | Placebo | -1.43 | Standard Deviation 8.73 | mg/dL | |
| C-Reactive Protein (CRP) Levels. | Indomethacin Suppository | -2.08 | Standard Deviation 12.55 | mg/dL | |
| Number of Participants Who Development of Organ Failure | Placebo | 6 | Participants | ||
| Number of Participants Who Development of Organ Failure | Indomethacin Suppository | 3 | Participants | ||
| Mortality | Placebo | 1 | Participants | ||
| Mortality | Indomethacin Suppository | 0 | 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 | 24 | |
| Overall Study | STARTED | Indomethacin Suppository | 18 | |
| Overall Study | COMPLETED | Placebo | 24 | |
| Overall Study | COMPLETED | Indomethacin Suppository | 18 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Indomethacin Suppository | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Acute Kidney Injury | Renal and urinary disorders | Placebo | 1 | 24 | 1 |
| other | Acute Kidney Injury | Renal and urinary disorders | Indomethacin Suppository | 0 | 18 | 0 |
| other | GI Bleed | Gastrointestinal disorders | Placebo | 1 | 24 | 1 |
| other | GI Bleed | Gastrointestinal disorders | Indomethacin Suppository | 0 | 18 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 24 |
| Total, all-cause mortality | Indomethacin Suppository | 0 | 18 |
| Total, other adverse events | Placebo | 2 | 24 |
| Total, other adverse events | Indomethacin Suppository | 0 | 18 |
| Total, serious adverse events | Placebo | 0 | 24 |
| Total, serious adverse events | Indomethacin Suppository | 0 | 18 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Indomethacin Suppository vs Placebo: Mortality | Trial comparisons |
| Indomethacin Suppository vs Placebo: Number of Participants Who Development of Organ Failure | Trial comparisons |
| Indomethacin Suppository vs Placebo: deaths from any cause | Trial comparisons |
| Indomethacin Suppository 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/NCT02692391
GET https://conductscience.org/api/trials/v1/NCT02692391/registered