DRUG
Indomethacin
One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.
Trial of Indomethacin in Chronic Pancreatitis
Status
Completed
Phase
Phase 1 / Phase 2
Enrollment
27
Locations
2
Results
Posted
Publications
1
Study summary
What the protocol is testing.
The researchers are trying to find a way to slow down the progression of chronic pancreatitis (CP) and investigate the possibility of the long term treatment of this disease.
Interventions
Treatment arms and agents.
DRUG
Placebo
One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.
PROCEDURE
Endoscopy for Pancreatic Function Testing
All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
Timeline
From registration to results.
First posted
Dec 20, 2019
Study start
Jul 15, 2020
Primary completion
Apr 24, 2023
Study completion
Apr 24, 2023
Results posted
Sep 4, 2024
Registry updated
Sep 4, 2024
Outcomes
What the study measures.
Primary outcomes
Change in Prostaglandin E2 (PGE2) Concentrations
Time frame · Baseline, 28 days
Mean change in PGE2 concentrations in pancreas fluid before and after intervention
Secondary outcomes
Changes in Pain Interference Score
Time frame · 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.
Change in Quality of Life (Mental Health)
Time frame · 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..
Change in Pain Composite Score
Time frame · 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.
Change in Quality of Life (Physical Health)
Time frame · 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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: 1. Any gender, age ≥ 18 years and \< 60 years 2. Diagnosed with chronic pancreatitis per American Pancreatic Association guidelines (pancreatic calcifications and/or Cambridge 3-4 changes on CT, MRI, and/or ERCP) 3. Scheduled for an upper GI endoscopic procedure (EGD or EUS) for clinical or research) indications (not conflicting with current investigation). 4. Able to provide written informed consent. 5. Serum creatinine within normal laboratory range, as measured within 30 days of the baseline study endoscopy. 6. For females of reproductive potential: willing to use highly effective contraception while taking study medication and for an additional 5 days after completing study medication. Exclusion Criteria: 1. Diagnosed with acute pancreatitis requiring hospitalization within the 6 weeks prior to study enrollment. 2. Habitual use of aspirin or non-steroidal anti-inflammatory medications (NSAIDs), defined as use more than once per week. 3. Any use of aspirin or NSAIDs within 1 week of baseline study endoscopy procedure. 4. Allergy to secretin, indomethacin or NSAIDs. 5. History of known chronic renal insufficiency or cirrhosis. 6. History of coronary artery disease, angina pectoris, myocardial infarction, cerebrovascular accident (stroke), or transient ischemic accident (TIA). 7. History of peptic ulcer or gastrointestinal bleeding. 8. Incarcerated. 9. Found to have active GI ulceration at the time of baseline endoscopy. 10. Hospitalized for acute pancreatitis while participating in this research protocol. Participants who are hospitalized for an episode of acute pancreatitis during study participation will be withdrawn from the study, and considered non-accrued.
Study locations
2 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Mayo Clinic
Rochester, Minnesota, United States
Ohio State University
Columbus, Ohio, United States
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