A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome

Study Overview
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Brief Summary
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To evaluate the safety and tolerability, treatment effect on abdominal pain, and dose response of MD-7246 administered orally to patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

Official Title
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A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Study of MD-7246 Administered Orally for 12 Weeks to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome With Diarrhea (IBS-D)

Intervention / Treatment
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* Drug: MD-7246
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient meets the Rome IV criteria for diagnosis of IBS-D Patient maintains a minimum level of compliance with daily diary Female patients of childbearing potential must agree to use one of the following methods of birth control: Hormonal contraception Double-barrier method Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy Exclusion Criteria: Patient has clinically significant findings on a physical examination and/or clinical laboratory tests Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments NOTE: Additional inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MD-7246 300 μg<br>1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets | Drug: MD-7246<br>* Oral tablet<br>Drug: Placebo<br>* Matching oral tablet<br>|
| Experimental: MD-7246 600 μg<br>2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets | Drug: MD-7246<br>* Oral tablet<br>Drug: Placebo<br>* Matching oral tablet<br>|
| Experimental: MD-7246 1200 μg<br>4 MD-7246 300-μg oral tablets | Drug: MD-7246<br>* Oral tablet<br>|
| Placebo Comparator: Placebo<br>4 matching placebo oral tablets | Drug: Placebo<br>* Matching oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period | Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with no abdominal pain and 10 is anchored with worst possible abdominal pain. The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week. Weekly change from baseline was calculated for each week as the weekly score minus the baseline score. Mixed model repeated measures (MMRM) results are based on a repeated measures analysis with treatment, analysis week, and treatment-by-week interaction as fixed effects and baseline as covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect. Baseline is derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization. | Baseline, up to Week 12 (end of the Treatment Period) | 
| Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders | A 6/12 Week Abdominal Pain 30% Responder was a participant who had a decrease from baseline of ≥30% in the weekly abdominal pain score for that week for at least 6 out of the 12 weeks of the Treatment Period; for any week, a participant with < 4 daily abdominal pain scores available was considered a non-responder for that week. Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with no abdominal pain and 10 is anchored with worst possible abdominal pain. The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week. | Baseline through Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal pain, Diarrhea, Irritable Bowel Syndrome