Conditions: Opioid-Induced Constipation
Keywords: Opioid-Induced Constipation Linaclotide Linzess
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 254
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast. arm 2: Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast. arm 3: Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.

Interventions: intervention 1: Linaclotide 145 micrograms intervention 2: Linaclotide 290 micrograms intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Matching placebo

Protocol document: