Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation
Summary
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.
Timeline
- Start
- 2009-07
- Primary completion
- 2010-07
- Completion
- 2010-08
Outcome
Met primary endpoint
registry Placebo vs Linaclotide; p = 0.0004; Odds Ratio (OR) 2.60 (95% CI 1.51 to 4.47) NCT00948818 ↗
registry Placebo vs Linaclotide; p <0.0001; Odds Ratio (OR) 3.65 (95% CI 2.26 to 5.88) NCT00948818 ↗
registry Placebo vs Linaclotide; p = 0.0262; Odds Ratio (OR) 1.41 (95% CI 1.04 to 1.91) NCT00948818 ↗
registry Placebo vs Linaclotide; p <0.0001; Odds Ratio (OR) 1.93 (95% CI 1.40 to 2.66) NCT00948818 ↗
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 |