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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

NCT02270983 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2019-04-08

Study results available
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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.

Conditions

  • Opioid-Induced Constipation

Interventions

DRUG

Linaclotide 145 micrograms

DRUG

Linaclotide 290 micrograms

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • Ironwood Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Patricia D'Astoli, RN · Forest Laboratories, LLC, an Allergan Affiliate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-08-31
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02270983 on ClinicalTrials.gov