A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
Summary
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).
Timeline
- Start
- 2019-05-01
- Primary completion
- 2020-02-26
- Completion
- 2020-03-11
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs MD-7246 300 μg; p = 0.7467; Least squares (LS) mean difference 0.08 (95% CI -0.42 to 0.58); MMRM NCT03931785 ↗
registry analysis (superiority test); Placebo vs MD-7246 600 μg; p = 0.0941; LS mean difference 0.43 (95% CI -0.07 to 0.93); MMRM NCT03931785 ↗
registry analysis (superiority test); Placebo vs MD-7246 300 μg; p = 0.8852; Odds Ratio (OR) 1.043 (95% CI 0.591 to 1.839); Cochran-Mantel-Haenszel NCT03931785 ↗
release “MD-7246 in adult patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D). The Phase II trial did not meet its primary” ironwoodpharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MD-7246 | Unknown | 300 ug | Oral |
| Subject | MD-7246 | Unknown | 600 ug | Oral |
| Subject | MD-7246 | Unknown | 1200 ug | Oral |