Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
Summary
The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.
Timeline
- Start
- 2014-10
- Primary completion
- 2015-08
- Completion
- 2015-08
Outcome
Met primary endpoint
registry NUMBER 72 μg Linaclotide: Responder: 13.4 percentage of participants NCT02291679 ↗
registry analysis (superiority test); Placebo vs 72 μg Linaclotide; p < 0.0001; Odds Ratio (OR) 3.03 (95% CI 1.76 to 5.20) NCT02291679 ↗
release “Phase III clinical trial of its 72 mcg dose of linaclotide in adults with chronic idiopathic constipation (CIC) met the primary endpoint.” ironwoodpharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linaclotide | Peptide | 72 ug | Oral |
| Subject | Linaclotide | Peptide | 145 ug | Oral |