drugset / Trial / NCT00938717
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).
Timeline
- Start
- 2009-07
- Primary completion
- 2010-09
- Completion
- 2010-09
Outcome
Met primary endpoint
registry Placebo vs Linaclotide; p <0.0001; Odds Ratio (OR) 4.65 (95% CI 2.44 to 8.84) NCT00938717 ↗
registry Placebo vs Linaclotide; p <0.0001; Odds Ratio (OR) 4.19 (95% CI 2.50 to 7.03) NCT00938717 ↗
registry Placebo vs Linaclotide; p <0.0001; Odds Ratio (OR) 2.62 (95% CI 1.91 to 3.60) NCT00938717 ↗
registry Placebo vs Linaclotide; p <0.0001; Odds Ratio (OR) 3.16 (95% CI 2.22 to 4.49) NCT00938717 ↗
Publications
- Rao SS, Quigley EM, Shiff SJ, Lavins BJ, Kurtz CB, MacDougall JE, Currie MG, Johnston JM. Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. Clin Gastroenterol Hepatol. 2014 Apr;12(4):616-23. doi: 10.1016/j.cgh.2013.09.022. Epub 2013 Sep 25.
- Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linaclotide | Peptide | 290 ug | Oral |