Comparison of Rimegepant and Placebo for Pain in IBS (NCT06221111) | Clinical Trial Compass
CompletedPhase 2
Comparison of Rimegepant and Placebo for Pain in IBS
United States24 participantsStarted 2024-06-06
Plain-language summary
The primary aim of this study is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 1 of the 2 run-in weeks for enrollment.
* Participants will be capable of providing informed consent.
Exclusion criteria:
* Diagnosis of moderate-severe depression as per BDI ≥18;
* 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/m…