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

Browse trials for

• Irritable Bowel Syndrome 1,062
• Syndrome 9,217
• Diarrhea 852
• Abdominal Pain 338

Keywords

• Abdominal pain
• Diarrhea
• Irritable Bowel Syndrome

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 515 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Lead sponsor

Ironwood Pharmaceuticals, Inc. is the lead sponsor of 24 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Study arms

• Experimental
  MD-7246 300 μg

  1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets

  Drug: MD-7246 · Drug: Placebo

• Experimental
  MD-7246 600 μg

  2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets

  Drug: MD-7246 · Drug: Placebo

• Experimental
  MD-7246 1200 μg

  4 MD-7246 300-μg oral tablets

  Drug: MD-7246

• Placebo comparator
  Placebo

  4 matching placebo oral tablets

  Drug: Placebo

Interventions

• DrugMD-7246

  Oral tablet

• DrugPlacebo

  Matching oral tablet

Primary outcomes

1. 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.

   Time frame: Baseline, up to Week 12 (end of the Treatment Period)

2. 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.

   Time frame: Baseline through Week 12

Baseline characteristics

Study documents

• Study protocol · Jan 29, 2019
• Statistical analysis plan · Apr 14, 2020

Documents are hosted by the registry — open the source record to download them.