drugset / Trial / NCT02837783
A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)
Phase 4
Terminated
20 enrolled
Ironwood Pharmaceuticals, Inc.
Manchester University NHS Foundation Trust · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of this trial is to determine the effect of linaclotide on abdominal girth in IBS-C participants with the baseline symptoms of abdominal bloating and an increased abdominal girth.
Timeline
- Start
- 2016-12-21
- Primary completion
- 2018-10-31
- Completion
- 2018-10-31
Outcome
Missed primary endpoint
Stopped (Enrollment): “Insufficient enrollment”
registry analysis (superiority test); Matching Placebo vs 290 μg Linaclotide; p = 0.283; Wilcoxon rank sum test NCT02837783 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linaclotide | Peptide | 290 ug | Oral |