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Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist

Rimegepant for Irritable Bowel Syndrome

Phase 2

Recruiting

Led By Michael Camilleri

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants will be 18-65 years of age.

Participants will have subjective pain ratings by a Likert scale of at least >3.0 for enrollment.

Must not have

Participants who report nausea several times per week or daily on the baseline bowel disease questionnaire (question # 16)

Severe hepatic or renal impairment, such as baseline AST or ALT >2.5 X upper normal limit or end-stage renal disease with estimated glomerular filtration rate or creatinine clearance <15mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during days 26-28 of 4 week study

Summary

This trial aims to see if rimegepant can help reduce abdominal pain in people with irritable bowel syndrome (IBS) that is not caused by constipation.

Who is the study for?

Adults aged 18-65 with non-constipation IBS and chronic abdominal pain can join this trial. They must have a documented diagnosis, experience significant pain, and be able to consent. Excluded are those with severe depression, substance abuse issues, certain medical conditions like liver or kidney disease, recent changes in pain medication, or women who could be pregnant.

What is being tested?

The study is testing if Rimegepant (a drug currently used for migraines) can reduce stomach pain in people with Irritable Bowel Syndrome that doesn't involve constipation. Participants will either receive Rimegepant or a placebo to compare the effectiveness.

What are the potential side effects?

While not specified here, common side effects of Rimegepant may include nausea, dizziness and dry mouth based on its use for treating migraines. Each person's reaction to the medication can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My pain level is more than 3 on a scale.

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I have IBS without constipation and chronic abdominal pain for over 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I experience nausea several times a week or daily.

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I do not have severe liver or kidney problems.

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I am not taking strong medication that affects liver enzyme activity.

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My depression is moderate to severe, based on a test score.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during days 26-28 of 4 week study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during days 26-28 of 4 week study

This trial's timeline: 3 weeks for screening, Varies for treatment, and during days 26-28 of 4 week study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

abdominal pain

Secondary study objectives

colonic transit

rectal compliance

rectal sensation

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: rimegepantExperimental Treatment1 Intervention

* Rimegepant 75mg oral dissolving tablet (ODT) * Formulation and Dosing as FDA-approved for Migraine Prevention: 75 mg Every Other Day (EOD) for 4 weeks/30 days

Group II: placeboPlacebo Group1 Intervention

Placebo ODT appearing identical to the experimental formulation and administered every other day for 4 weeks/30 days

0 / 7Eligibility criteria met