Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain

Summary

The purpose of this study was to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been present for a minimum of 3 months. This study included up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients meeting the entry criteria were randomized to 1 of 2 doses of linaclotide or placebo once per day for 8 weeks. This 8-week study assessed the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of OIC.

Timeline

Start

2014-10-31

Primary completion

2015-08-31

Completion

2015-10-31

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Linaclotide 145 Micrograms; p = 0.0035; Least squares mean difference 1.325 (95% CI 0.439 to 2.211); ANCOVA NCT02270983 ↗

registry analysis (superiority test); Placebo vs Linaclotide 290 Micrograms; p <0.0001; Least squares mean difference 1.908 (95% CI 1.021 to 2.796); ANCOVA NCT02270983 ↗

release “the Phase II clinical trial of linaclotide conducted in adults with opioid-induced constipation (OIC) met its primary endpoint.” ironwoodpharma.com ↗

Publications

• Brenner DM, Argoff CE, Fox SM, Bochenek W, D'Astoli P, Blakesley RE, Reasner DS, O'Dea CR, Cash BD. Efficacy and safety of linaclotide for opioid-induced constipation in patients with chronic noncancer pain syndromes from a phase 2 randomized study. Pain. 2020 May;161(5):1027-1036. doi: 10.1097/j.pain.0000000000001754.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Linaclotide	Peptide	145 ug	Oral
Subject	Linaclotide	Peptide	290 ug	Oral

Indications