drugset / Trial / NCT02387359
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
RandomizedParallel-groupTriple-blindTreatment
Summary
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.
Timeline
- Start
- 2014-12
- Primary completion
- 2016-12
- Completion
- 2017-02
Publications
- Brenner DM, Shin AS, Laitman AP, Deutsch JK, Kunkel DC. The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint. J Gastroenterol Hepatol. 2025 Dec;40(12):2890-2897. doi: 10.1111/jgh.70119. Epub 2025 Nov 10.
- Cash BD, Sharma A, Walker A, Laitman AP, Chang L. Plecanatide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: Post hoc analyses of placebo-controlled trials in adults with severe constipation. Neurogastroenterol Motil. 2023 Sep;35(9):e14632. doi: 10.1111/nmo.14632. Epub 2023 Jun 18.
- Menees SB, Franklin H, Chey WD. Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older. Clin Ther. 2020 Jul;42(7):1406-1414.e4. doi: 10.1016/j.clinthera.2020.05.012. Epub 2020 Jul 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Plecanatide | Peptide | 3 mg | Oral |
| Comparator | Plecanatide | Peptide | 6 mg | Oral |