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Nonsteroidal Anti-inflammatory Drug

Indomethacin for Chronic Pancreatitis

Phase 2
Waitlist Available
Led By Santhi Vege, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 28 days
Awards & highlights

Study Summary

This trial is testing if a new medication can help slow the progression of chronic pancreatitis and improve long-term outcomes.

Eligible Conditions
  • Chronic Pancreatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in prostaglandin E2 (PGE2) concentrations
Secondary outcome measures
Changes in pain
Changes in quality of life

Side effects data

From 2014 Phase 4 trial • 270 Patients • NCT01957215
1%
Vascular rupture
1%
Drug eruption
1%
Gingival bleeding
1%
Application site pruritis
1%
Inflammation
1%
Upper respiratory tract infections
1%
Nasopharyngitis
1%
Ligament sprain
1%
Pruritis
1%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Indomethacin Patch
Placebo Patch

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral indomethacin 50 mg po BIDExperimental Treatment1 Intervention
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.
Group II: Placebo po BIDPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indomethacin
2011
Completed Phase 4
~4130

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,054 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,157 Total Patients Enrolled
Santhi Vege, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total recruitment for this clinical trial?

"The data on clinicaltrials.gov does suggest that this study is currently recruiting patients. The trial was initially posted on 7/15/2020 and was last edited on 5/2/2022. The trial is searching for 32 participants between 2 locations."

Answered by AI

Are there any critical dangers associated with Indomethacin?

"There is some clinical data supporting Indomethacin's safety, but nothing yet for efficacy. It received a score of 2."

Answered by AI

To what sort of medical ailments is Indomethacin commonly prescribed?

"Indomethacin is the standard medication for myalgia. Additionally, it can be used to treat ankylosing spondylitis, pain, and other conditions where the patient does not respond well to other therapies."

Answered by AI

Could you please elaborate on other Indomethacin research projects?

"Vanderbilt University Autonomic Dysfunction Center was the first to study indomethacin in 1997 and, 301 trials later, the drug is still being investigated. There are 15 ongoing clinical trials recruiting patients as of now, with a significant number of these based in Rochester, Minnesota."

Answered by AI

For whom is this experiment looking for participants?

"Individuals that suffer from pancreatitis on a chronic basis and are aged 18-60 may be eligible for this study. Currently, the clinical trial is looking for 32 more participants."

Answered by AI

Will this clinical trial be testing on patients over the age of 20 years?

"As this trial's inclusion criteria state, the minimum age for participation is 18 years old and the maximum is 60."

Answered by AI

Are there any more available spots for participants in this research project?

"Yes, as of today, this study is still looking for volunteers. According to the clinicaltrials.gov website, the posting date was July 15th, 2020 and the most recent edit was on May 2nd, 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial of Indomethacin in Chronic Pancreatitis
Santhi Swaroop Vege 2020. "Trial of Indomethacin in Chronic Pancreatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04207060.
~6 spots leftby Apr 2025
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