drugset / Trial / NCT00765882
Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder
Timeline
- Start
- 2008-09
- Primary completion
- 2009-07
- Completion
- 2009-08
Outcome
Met primary endpoint
registry Placebo vs Linaclotide 145µg; p = 0.0012; Odds Ratio (OR) 2.93 (95% CI 1.50 to 5.72) NCT00765882 ↗
registry Placebo vs Linaclotide 290µg; p <0.0001; Odds Ratio (OR) 4.22 (95% CI 2.20 to 8.10) NCT00765882 ↗
Publications
- Chang L, Lembo AJ, Lavins BJ, Shiff SJ, Hao X, Chickering JG, Jia XD, Currie MG, Kurtz CB, Johnston JM. The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials. Aliment Pharmacol Ther. 2014 Dec;40(11-12):1302-12. doi: 10.1111/apt.12985. Epub 2014 Oct 13.
- Lembo AJ, Schneier HA, Shiff SJ, Kurtz CB, MacDougall JE, Jia XD, Shao JZ, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Eng P, Fox SM, Johnston JM. Two randomized trials of linaclotide for chronic constipation. N Engl J Med. 2011 Aug 11;365(6):527-36. doi: 10.1056/NEJMoa1010863.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linaclotide | Peptide | 145 ug | Oral |
| Subject | Linaclotide | Peptide | 290 ug | Oral |