Back to resultsTrial of Indomethacin in Chronic Pancreatitis
Primary Purpose
Chronic Pancreatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Indomethacin
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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 Participants who are hospitalized for an episode of acute pancreatitis during study participation will be withdrawn from the study, and considered non-accrued.
Sites / Locations
- Mayo Clinic
- Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oral indomethacin 50 mg po BID
Placebo po BID
Arm Description
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed NSAID. Commercially available indomethacin will be utilized in this study. One capsule orally BID for 28 days. Those in the indomethacin arm will receive indomethacin 50 mg BID. 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.
Participants in both study arms will receive study medication, one capsule orally BID for 28 days. Those in the placebo arm will receive placebo capsules BID. 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.
Outcomes
Primary Outcome Measures
Change in prostaglandin E2 (PGE2) concentrations
Mean change in PGE2 concentrations
Secondary Outcome Measures
Changes in pain
Measured using the self reported Brief Pain Inventory questionnaire
Changes in quality of life
Measured using the self reported PROMIS Global quesionnaire
Full Information
NCT ID
NCT04207060
First Posted
December 17, 2019
Last Updated
September 11, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04207060
Brief Title
Trial of Indomethacin in Chronic Pancreatitis
Official Title
Phase 1/2 Trial of Indomethacin in Chronic Pancreatitis (The PAIR Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Subjects will be assigned to receive IN or placebo according to a computer generated randomization list composed of randomized blocks of sizes of 2 or 4. Two separate sets of blocks will be created, one for subjects with alcoholic CP and the other for those with other causes of CP. Within each block, equal number of subjects will be assigned to IN and placebo. Separate sets of blocks will be provided for Mayo 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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinding: Study medication will be labelled "indomethacin 50 mg or placebo capsule" with the subject's name, hospital or clinic number, study IRB number, and subject number. Placebo and IN capsules will be identical in appearance. The investigators, study coordinator, and clinical caregivers will remain blinded to subject allocation throughout the data ascertainment and data entry phase of the study.
The success of blinding will be evaluated by asking the investigator, the study coordinator, and the subject the following question during each telephone follow-up visit: "Which treatment group is this subject/were you assigned to: placebo, active drug, or unsure?"
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral indomethacin 50 mg po BID
Arm Type
Experimental
Arm Description
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed NSAID. Commercially available indomethacin will be utilized in this study. One capsule orally BID for 28 days. Those in the indomethacin arm will receive indomethacin 50 mg BID. 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.
Arm Title
Placebo po BID
Arm Type
Placebo Comparator
Arm Description
Participants in both study arms will receive study medication, one capsule orally BID for 28 days. Those in the placebo arm will receive placebo capsules BID.
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.
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Intervention Description
50 mg twice a day by mouth.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Lactose capsules not containing active study drug will be taken twice a day.
Primary Outcome Measure Information:
Title
Change in prostaglandin E2 (PGE2) concentrations
Description
Mean change in PGE2 concentrations
Time Frame
Baseline, 28 days
Secondary Outcome Measure Information:
Title
Changes in pain
Description
Measured using the self reported Brief Pain Inventory questionnaire
Time Frame
Baseline, 28 days
Title
Changes in quality of life
Description
Measured using the self reported PROMIS Global quesionnaire
Time Frame
Baseline, 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santhi Vege, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials.
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Trial of Indomethacin in Chronic Pancreatitis
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