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Comparison of Rimegepant and Placebo for Pain in IBS

CompletedPhase 2NCT06221111
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The primary aim of this study is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS.

Study details

Official title
Rimegepant, a CGRP Antagonist, in the Treatment of Visceral Sensation and Chronic Abdominal Pain: A Pilot Study
Interventions
  • Drug: Rimegepant 75 MG [Nurtec]
Sponsor
Mayo Clinic
Collaborators
Pfizer
Start date
2024-06-06
Primary completion
2025-05-30
Sex
All
Age range
from 18 Years to 70 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Twenty-four participants with non-constipation IBS and chronic abdominal pain will be recruited for enrollment. Participants will meet specific Rome III IBS diagnostic criteria. Inclusion criteria: * Participants will be 18-70 years of age. * Participants will have non-constipation IBS \[that is IBS-D (diarrhea), IBS-M (mixed), or IBS-U (unspecified)\] with chronic abdominal pain diagnosed in their medical records at Mayo Clinic with chronic pain documented for ≥ 3 months. * Participants will have subjective pain ratings of ≥ 30 on the 100 mm VAS during at least 7 consecutive days of the 2 week run-in period for enrollment. * Participants will be capable of providing informed consent. Exclusion criteria: * Diagnosis of moderate-severe depression as per HADS ≥15; * Alcohol or illicit substance dependence or abuse in the past 12 months; * Dementia, unprovoked seizure history, seizure disorder; * Pregnancy (all women of childbearing potential will be required to have a negative pregnancy test prior to initiation, and will be on a highly effective method of contraception, as detailed in the consent form); * Significant change or increase in antidepressant or pain medications within the last four weeks; significant change in primary treatment interventions for pain in the past four weeks; * Medically unstable * 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. Although Rimegepant is rarely associated with abnormal circulating liver enzymes, we shall exclude patients with baseline AST or ALT greater than 2.5 times the upper limit of normal. * Concomitant use of strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers. * Participants who report nausea several times per week or daily on the baseline bowel disease questionnaire (question # 16) will be excluded from the study because of the low risk of nausea induced by the treatment which was estimated at approximately 3% for rimegepant compared to 1% for placebo.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06221111