Trial · NCT04207060
Trial of Indomethacin in Chronic Pancreatitis
NCT04207060, Phase 1, Phase 2, Completed, Mayo Clinic; results first posted 2024-09-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Indomethacin in Chronic Pancreatitis. Trials, record NCT04207060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04207060
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Indomethacin in Chronic Pancreatitis
- NCT number
- NCT04207060
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Chronic Pancreatitis
- Interventions
- Indomethacin, Placebo, Endoscopy for Pancreatic Function Testing
- First posted
- 2019-12-20
- Last updated
- 2024-09-04
- Results first posted
- 2024-09-04
- Limitations and caveats
Limitations include the short treatment period as participants received the study medication for only 28 days, which may be too short to detect a significant biochemical change in a chronic disease such as chronic pancreatitis. Additionally, as this was a Phase 1/2 study, the only dose chosen for the intervention, indomethacin, was 50 mg BID, which may not represent an effective dose to modify chronic pancreatitis. Furthermore, the short follow-up period limits ascertaining long-term effects.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Prostaglandin E2 (PGE2) Concentrations | Baseline, 28 days | Mean change in PGE2 concentrations in pancreas fluid before and after intervention |
| Secondary | Changes in Pain Interference Score | Baseline, 28 days | Measured using the self reported Brief Pain Inventory questionnaire. The pain interference subscale includes 7 items which each utilize a 11-point scale from 0-10, with 10 representing the worst outcome (highest level of pain). The scores from the 7 items are summed to create a total score. Thus, the total score can range from 0-70. The total pain interference score at baseline was then subtracted from the total pain interference score at 28 days to calculate the change in pain interference score. |
| Secondary | Change in Quality of Life (Mental Health) | Baseline, 28 days | Measured using the self reported PROMIS-10 instrument. The PROMIS-10 instrument includes 4 items for mental health, which each have 1-5 scale, with 5 representing the worst outcome. T-scores are then calculated from the raw scores. A mean T-score of 50 represents average health with a standard deviation of 10. Higher scores denote a worse outcome. The mean T-score at baseline was then subtracted from the mean T-score at 28 days to derive the change in mental quality of life.. |
| Secondary | Change in Pain Composite Score | Baseline, 28 days | Assessed using the Brief Pain Inventory (BPI) scale. The pain composite score includes 4 questions from the BPI, each of which is scored on a 0-10 scale with 10 representing the worst outcome (highest level of pain) and 0 representing the best outcome (no pain). The 4 questions assess 1) worst pain, 2) least pain, 3) average pain, and 4) current pain. The mean score of the responses to these 4 questions is calculated to derive the pain composite score. Thus, the pain composite score will also range from 0-10. The mean pain composite score at baseline was then subtracted from the mean pain composite score at 28 days to calculate the change in pain composite score. |
| Secondary | Change in Quality of Life (Physical Health) | Baseline, 28 days | Quality of life measured using the self reported PROMIS-10 instrument. The PROMIS-10 instrument includes 4 items for physical health, which each have a 1-5 scale, with 5 representing the worst outcome. T-scores are then calculated from the raw scores. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher T-scores represent worse outcomes. The mean T-score at baseline was then subtracted from the mean T-score at 28 days to derive the change in physical quality of life. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Prostaglandin E2 (PGE2) Concentrations | Baseline, 28 days | pg/ml | MEAN | |
| SECONDARY | Changes in Pain Interference Score | Baseline, 28 days | score on a scale | MEAN | |
| SECONDARY | Change in Quality of Life (Mental Health) | Baseline, 28 days | T-score | MEAN | |
| SECONDARY | Change in Pain Composite Score | Baseline, 28 days | score on a scale | MEAN | |
| SECONDARY | Change in Quality of Life (Physical Health) | Baseline, 28 days | T-score | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Prostaglandin E2 (PGE2) Concentrations | Indomethacin | -457.7 | Standard Deviation 489.8 | pg/ml | |
| Change in Prostaglandin E2 (PGE2) Concentrations | Placebo | -840.4 | Standard Deviation 865.6 | pg/ml | |
| Changes in Pain Interference Score | Indomethacin | -2.9 | Standard Deviation 3.6 | score on a scale | |
| Changes in Pain Interference Score | Placebo | -0.4 | Standard Deviation 1.3 | score on a scale | |
| Change in Quality of Life (Mental Health) | Indomethacin | -3.8 | Standard Deviation 10 | T-score | |
| Change in Quality of Life (Mental Health) | Placebo | 0.1 | Standard Deviation 6 | T-score | |
| Change in Pain Composite Score | Indomethacin | -1.3 | Standard Deviation 1.5 | score on a scale | |
| Change in Pain Composite Score | Placebo | -0.5 | Standard Deviation 1.4 | score on a scale | |
| Change in Quality of Life (Physical Health) | Indomethacin | 1.6 | Standard Deviation 5.4 | T-score | |
| Change in Quality of Life (Physical Health) | Placebo | 1.4 | Standard Deviation 5.2 | T-score |
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 | Indomethacin | 13 | |
| Overall Study | STARTED | Placebo | 14 | |
| Overall Study | COMPLETED | Indomethacin | 11 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | Indomethacin | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Nausea and Vomiting | Gastrointestinal disorders | Indomethacin | 1 | 13 | 1 |
| other | Nausea and Vomiting | Gastrointestinal disorders | Placebo | 1 | 14 | 1 |
| other | Headache | Nervous system disorders | Indomethacin | 1 | 13 | 1 |
| other | Headache | Nervous system disorders | Placebo | 0 | 14 | 0 |
| other | Shoulder Pain | Musculoskeletal and connective tissue disorders | Indomethacin | 0 | 13 | 0 |
| other | Shoulder Pain | Musculoskeletal and connective tissue disorders | Placebo | 1 | 14 | 1 |
| other | Bloating | Gastrointestinal disorders | Indomethacin | 1 | 13 | 1 |
| other | Bloating | Gastrointestinal disorders | Placebo | 0 | 14 | 0 |
| other | Hot Flashes | Endocrine disorders | Indomethacin | 0 | 13 | 0 |
| other | Hot Flashes | Endocrine disorders | Placebo | 1 | 14 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Indomethacin | 0 | 13 |
| Total, all-cause mortality | Placebo | 0 | 14 |
| Total, other adverse events | Indomethacin | 4 | 13 |
| Total, other adverse events | Placebo | 4 | 14 |
| Total, serious adverse events | Indomethacin | 0 | 13 |
| Total, serious adverse events | Placebo | 0 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40622408 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21DK117212 | Phase 1/2 Trial of Indomethacin in Chronic Pancreatitis (The PAIR Trial) | VEGE, SANTHI SWAROOP | MAYO CLINIC ROCHESTER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2019 to 2020 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Indomethacin vs Placebo: deaths from any cause | 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/NCT04207060
GET https://conductscience.org/api/trials/v1/NCT04207060/registered