Irritable Bowel SyndromePhase 2NCT06221111
Comparison of Rimegepant and Placebo for Pain in IBS
A Phase 2 study testing Rimegepant 75 MG [Nurtec] in people with Irritable Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary aim of this study is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Rimegepant 75 MG [Nurtec]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2024to 3 Jun 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Rimegepant, a CGRP Antagonist, in the Treatment of Visceral Sensation and Chronic Abdominal Pain: A Pilot Study
The primary aim of this study is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS.
Read the detailed description
Irritable bowel syndrome (IBS) and, particularly, the pain component of IBS lack effective treatments. Antispasmodics, antidepressants and hypnotherapy have all been proposed for the treatment of pain. Their effectiveness in clinical practice is disappointing, despite meta-analyses suggesting efficacy. The study hypotheses are: that rimegepant will be safe, well-tolerated, and will improve abdominal pain in participants with non-constipation IBS. The primary aim is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS. Secondary aims of this study are:
- 1: To describe the effect of rimegepant on rectal compliance in participants with IBS and chronic abdominal pain.
- 2: To evaluate the effects of rimegepant on rectal sensation based on ascending method of limits and on graded rapid phasic distensions in participants with non-constipation IBS and chronic abdominal pain.
- 3: To evaluate effects of rimegepant on overall colonic transit in participants with non-constipation IBS and chronic abdominal pain.
- 4: To evaluate safety of rimegepant in participants with non-constipation IBS and chronic abdominal pain Methods: IBS-pain participants will be selected according to the Rome III criteria. Trial participants will continue to receive the same medical therapy throughout the baseline and treatment periods. The study design is a randomized, double-blind placebo-controlled trial of rimegepant at doses and route of administration approved by the FDA for the prophylaxis of migraine headache.
The trial period will consist of a two week run-in period, and 4 week treatment period. Participants will complete a daily diary regarding abdominal pain and stool consistency. They will also complete questionnaires studies of anxiety and depression and IBS-QOL.
An established and validated method using rectal barostat device will be used to measure rectal compliance and sensation. The standard scintigraphic method to measure colonic transit established in the Clinical Research Trials Unit (CRTU) at Mayo Clinic Rochester will be used to evaluate changes in colonic transit.
Anticipated results and Significance: Rimegepant, at doses and mode of administration approved by FDA for the prophylaxis of migraine headache, will be efficacious in the reduction of abdominal pain and rectal sensation in participants with non-constipation IBS and abdominal pain.
This study will provide an early signal of efficacy that may lead to future randomized, controlled trials.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Rimegepant 75 MG [Nurtec]
- Keywords
- pain, IBS, CGRP, rimegepant, antagonist
- Medical subject headings
- Irritable Bowel Syndrome, Pain, Ichthyosis Bullosa of Siemens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimegepant 75 MG [Nurtec]Drug
Also called placebo
placebo controlled trial
| Study group | Role | What they receive |
|---|---|---|
| rimegepant | Experimental | * 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 Receives: Drug: Rimegepant 75 MG [Nurtec] |
| placebo | Placebo comparator | Placebo ODT appearing identical to the experimental formulation and administered every other day for 4 weeks/30 days Receives: Drug: Rimegepant 75 MG [Nurtec] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Abdominal Pain Scores
The change in daily abdominal pain scores will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score. Total scores range from 0 to 100 with higher scores indicating worse pain.
Measured: Baseline; Day 28
Secondary outcomes (9)
Change in Bowel Movement Frequency
The change in bowel movement frequency measured by the number of bowel movements a participant reported having each day from baseline through day 28.
Measured: Baseline; Day 28
Change in Rectal Compliance
The change in rectal compliance threshold defined as the change in pressure at half maximum volume (Pr 1/2) measured using a rectal barostat device. The rectal barostat device is a rectal catheter with a polyethylene bag attached (length 22 cm; capacity 600 ml) that is inserted into the rectum and connected to a barostat. The bag is unfolded by inflation with 75 ml of air, followed by complete deflation. After a 10 minute recovery period, the pressure is increased from 0 mmHg in steps of 4 mmHg for 15 seconds per step until 20 mmHg is reached. The observed volume/maximum observed volume will be used to obtain a pressure corresponding to half the maximum observed volume. A calculation of the pressures corresponding to the volumes just above and just below the half maximum volume will provided the specific pressure (Pr 1/2) corresponding to one half of the maximum observed volume.
Measured: Baseline; Day 28
Change in Rectal Sensation Pain Threshold
The change in rectal sensation pain threshold in response to the pressure in the balloon escalating from 0 mmHg to 44 mmHg at 4 mmHg stepwise increases measured using the 100-mm Visual analog scale (VAS). The scale ranges from (unnoticeable) to (unbearable). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "unnoticeable" on the left, and "unbearable" on the right. Participants will identify their level of pain by indicating a point on the line between each end. That point will be measured from the "unnoticeable" end, and the number of millimeters will be reported as the pain score. Total scores range from 0 to 100 with higher scores indicating worse pain.
Measured: Baseline; Day 28
Change in Rectal Sensation Ratings in Response to 24 and 36 mmHg Distensions
The change in rectal sensation ratings in response to 24 mmHg and 36 mmHg distensions measured using the 100-mm Visual analog scale (VAS). The scale ranges from (unnoticeable) to (unbearable). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "unnoticeable" on the left, and "unbearable" on the right. Participants will identify their sensation of pain, urgency and gas levels by indicating a point on the line between each end. That point will be measured from the "unnoticeable" end, and the number of millimeters will be reported as the pain, gas and urgency scores. Total scores range from 0 to 100 with higher scores indicating worsening sensation of pain, urgency and gas.
Measured: Baseline; Day 28
Gastric Emptying of Solids
Percentage of solids moved from the stomach to the small intestine (gastric emptying) at 4 hours on Day 28.
Measured: Day 28
Change in Colonic Transit at 24 Hours
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken at 4, 6, 8, 24, and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Measured: Baseline; Day 28
Colonic Transit at 48 Hours
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken at 4, 6, 8, 24, and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Measured: Day 28
Irritable Bowel Syndrome Quality of Life
Irritable Bowel Syndrome Quality of Life (IBS-QOL) is a self-reported measure used to assess the impact of irritable bowel syndrome (IBS) on a participant's quality of life. The IBS-QOL consists of 34 items that cover eight distinct sub-domains, including emotional well-being, social functioning, dietary habits and intimate relationships. Each item is rated on a 5-point Likert scale, ranging from 1 (not at all) to 5 (a great deal). The raw scores are converted to a 0-100 scale where higher scores indicate a better quality of life.
Measured: Baseline; Day 28; Day 56
Number of Participants Who Experienced an Adverse Event
The number of participants who experienced an Adverse Event.
Measured: Day 1; Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start6 Jun 2024
- Primary completion30 May 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind placebo-controlled trial of rimegepant at doses and route of administration approved by the FDA for the prophylaxis of migraine headache.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221111
- Sponsor's protocol ID
- 23-006559
- Status last verified
- Sep 2026
- First submitted
- 5 Jan 2024
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halawi H, Matar A, Wang I, Jencks KJ, Busciglio I, Eckert D, Harmsen WS, Camilleri M. A pilot, randomized, placebo-controlled trial of rimegepant on visceral sensation and symptoms in nonconstipation IBS pain. Am J Physiol Gastrointest Liver Physiol. 2026 Apr 1;330(4):G369-G380. doi: 10.1152/ajpgi.00394.2025. Epub 2026 Feb 4.
PubMed 41637861