Chronic PancreatitisPhase 1/2NCT04207060

Trial of Indomethacin in Chronic Pancreatitis

A Phase 1/2 study testing Indomethacin and Endoscopy for Pancreatic Function Testing in people with Chronic Pancreatitis, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Chronic Pancreatitis
What is being tested?: Indomethacin and Endoscopy for Pancreatic Function Testing
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 2 sitesUnited States
Study dates: 15 Jul 2020to 24 Apr 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Any gender, age ≥ 18 years and < 60 years
Diagnosed with chronic pancreatitis per American Pancreatic Association guidelines (pancreatic calcifications and/or Cambridge 3-4 changes on CT, MRI, and/or ERCP)
Scheduled for an upper GI endoscopic procedure (EGD or EUS) for clinical or research) indications (not conflicting with current investigation).
Able to provide written informed consent.
Serum creatinine within normal laboratory range, as measured within 30 days of the baseline study endoscopy.
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.

Who cannot join

Diagnosed with acute pancreatitis requiring hospitalization within the 6 weeks prior to study enrollment.
Habitual use of aspirin or non-steroidal anti-inflammatory medications (NSAIDs), defined as use more than once per week.
Any use of aspirin or NSAIDs within 1 week of baseline study endoscopy procedure.
Allergy to secretin, indomethacin or NSAIDs.
History of known chronic renal insufficiency or cirrhosis.
History of coronary artery disease, angina pectoris, myocardial infarction, cerebrovascular accident (stroke), or transient ischemic accident (TIA).

Show all 10Show fewer

History of peptic ulcer or gastrointestinal bleeding.
Incarcerated.
Found to have active GI ulceration at the time of baseline endoscopy.
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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Ohio State University
Columbus, Ohio, 43210
Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase 1/2 Trial of Indomethacin in Chronic Pancreatitis (The PAIR Trial)

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.

Conditions: Chronic Pancreatitis
Being tested: Indomethacin, Placebo, Endoscopy for Pancreatic Function Testing
Medical subject headings: Pancreatitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IndomethacinDrug
One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.
PlaceboDrug
One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function TestingProcedure or surgery
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.

Study groups in NCT04207060
Study group	Role	What they receive
Indomethacin	Experimental	The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications. Receives: Drug: Indomethacin; Procedure: Endoscopy for Pancreatic Function Testing
Placebo	Placebo comparator	Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication. Receives: Drug: Placebo; Procedure: Endoscopy for Pancreatic Function Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Prostaglandin E2 (PGE2) Concentrations
Mean change in PGE2 concentrations in pancreas fluid before and after intervention
Measured: Baseline, 28 days

Secondary outcomes (4)

Changes in Pain Interference Score
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.
Measured: Baseline, 28 days
Change in Quality of Life (Mental Health)
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..
Measured: Baseline, 28 days
Change in Pain Composite Score
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.
Measured: Baseline, 28 days
Change in Quality of Life (Physical Health)
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.
Measured: Baseline, 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202024 Apr 2023

First posted20 Dec 2019
Study start15 Jul 2020
Primary completion24 Apr 2023
Study completion24 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects will be assigned to receive indomethacin or placebo according to a computer generated randomization list composed of randomized blocks of sizes of 2 or 4. Within each block, equal number of subjects will be assigned to indomethacin and placebo. Separate sets of blocks will be provided for Mayo Clinic and Ohio State. The randomization lists will be computer generated by the study statistician (Dr Li), and kept in a secure computer file and paper study binder in the Mayo and Ohio State Research Pharmacies. No investigators or study personnel other than Dr Li will have knowledge of the randomization list. Dr Li will not participate in any aspect of subject recruitment, subject allocation, conduct of the study, or data ascertainment, but will perform data analysis.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04207060
Sponsor's protocol ID: 18-008193
Other IDs: R21DK117212
Status last verified: Aug 2024
First submitted: 17 Dec 2019
Last updated: 4 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Han S, Vege SS, Hart PA, Saloman JL, Xu J, Li L, Cruz-Monserrate Z, Palermo TM, Hill R, Hao W, Yadav D, Topazian M, Conwell DL. Oral Indomethacin for Chronic Pancreatitis: Results From the PAIR Randomized Placebo-Controlled Trial. Clin Transl Gastroenterol. 2025 Sep 1;16(9):e00888. doi: 10.14309/ctg.0000000000000888.
PubMed 40622408

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1/2 Trial of Indomethacin in Chronic Pancreatitis (The PAIR Trial)
ClinicalTrials.gov ID: NCT04207060
Acronym / sponsor ID: 18-008193
Conditions: Chronic Pancreatitis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 15 Jul 2020 (actual)
Primary completion: 24 Apr 2023 (actual)
Study completion: 24 Apr 2023 (actual)
First posted: 20 Dec 2019 (actual)
Results: Posted 4 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Subjects will be assigned to receive indomethacin or placebo according to a computer generated randomization list composed of randomized blocks of sizes of 2 or 4. Within each block, equal number of subjects will be assigned to indomethacin and placebo. Separate sets of blocks will be provided for Mayo Clinic and Ohio State. The randomization lists will be computer generated by the study statistician (Dr Li), and kept in a secure computer file and paper study binder in the Mayo and Ohio State Research Pharmacies. No investigators or study personnel other than Dr Li will have knowledge of the randomization list. Dr Li will not participate in any aspect of subject recruitment, subject allocation, conduct of the study, or data ascertainment, but will perform data analysis.

Arm	Type	Receives
Indomethacin	Experimental	Drug: Indomethacin, Procedure: Endoscopy for Pancreatic Function TestingThe study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.
Placebo	Placebo comparator	Drug: Placebo, Procedure: Endoscopy for Pancreatic Function TestingParticipants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Any gender, age ≥ 18 years and < 60 years
Diagnosed with chronic pancreatitis per American Pancreatic Association guidelines (pancreatic calcifications and/or Cambridge 3-4 changes on CT, MRI, and/or ERCP)
Scheduled for an upper GI endoscopic procedure (EGD or EUS) for clinical or research) indications (not conflicting with current investigation).
Able to provide written informed consent.
Serum creatinine within normal laboratory range, as measured within 30 days of the baseline study endoscopy.

Key exclusion criteria (10 listed)

Diagnosed with acute pancreatitis requiring hospitalization within the 6 weeks prior to study enrollment.
Habitual use of aspirin or non-steroidal anti-inflammatory medications (NSAIDs), defined as use more than once per week.
Any use of aspirin or NSAIDs within 1 week of baseline study endoscopy procedure.
Allergy to secretin, indomethacin or NSAIDs.
History of known chronic renal insufficiency or cirrhosis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IndomethacinOne capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.	Drug	Indomethacin
PlaceboOne capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.	Drug	Placebo
Endoscopy for Pancreatic Function TestingAll 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.	Procedure or surgery	Indomethacin, Placebo

Primary outcome

Change in Prostaglandin E2 (PGE2) Concentrations
Time frame: Baseline, 28 days
Mean change in PGE2 concentrations in pancreas fluid before and after intervention

4 secondary outcomes

Changes in Pain Interference Score
Time frame: Baseline, 28 days
Change in Quality of Life (Mental Health)
Time frame: Baseline, 28 days
Change in Pain Composite Score
Time frame: Baseline, 28 days
Change in Quality of Life (Physical Health)
Time frame: Baseline, 28 days

Results and safety

Results posted to the registry on 4 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Indomethacin	13	11
Placebo	14	14

Primary outcome: Change in Prostaglandin E2 (PGE2) Concentrations

Time frame: Baseline, 28 days. Mean (Standard Deviation). Unit: pg/ml

Measure	Indomethacin n = 13	Placebo n = 14
Value	-457.7 (489.8)	-840.4 (865.6)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indomethacin	0 of 13 (0%)	4 of 13 (30.8%)	0 of 13
Placebo	0 of 14 (0%)	4 of 14 (28.6%)	0 of 14

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40622408Han S, Vege SS, Hart PA, Saloman JL, Xu J, Li L, Cruz-Monserrate Z, Palermo TM, Hill R, Hao W, Yadav D, Topazian M, Conwell DL. Oral Indomethacin for Chronic Pancreatitis: Results From the PAIR Randomized Placebo-Controlled Trial. Clin Transl Gastroenterol. 2025 Sep 1;16(9):e00888. doi: 10.14309/ctg.0000000000000888.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Santhi Vege, MD principal investigator

Mayo Clinic

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Indomethacin and Endoscopy for Pancreatic Function Testing in people with Chronic Pancreatitis, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Prostaglandin E2 (PGE2) Concentrations (time frame: Baseline, 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04207060, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.