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

• Status: Completed
• Trial end date: 2015-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Ironwood Pharmaceuticals, Inc.
• Treatments: Analgesics, Opioid; Linaclotide

Criteria

Inclusion Criteria:

• Patient has chronic non-cancer pain that has been present for a minimum of 3 months

• Patient has been receiving a stable oral dose of a full-opioid agonist for at least 4 days per week during the 8 consecutive weeks

• Patient meets protocol criteria for Opioid-Induced Constipation (OIC): < 3 spontaneous bowel movements (SBMs) per week and reports one of the following symptoms for at least 4 weeks:

1. Straining during > 25% of BMs

2. Lumpy or hard stools during > 25% of BMs

3. Sensation of incomplete evacuation during > 25% of BMs

• Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines

• Patient has successfully completed protocol procedures (with no clinically significant findings)

• Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting

• Patient has a total of < 6 SBMs in IVRS during the 14 days before and up to the time of Randomization

• Patient has adequate relief and well-controlled pain with current dose of opioid

Exclusion Criteria:

• Patient has been using opioids for abdominal pain

• Patient has symptoms of or been diagnosed with chronic constipation or chronic idiopathic constipation prior to initiation of opioid treatment

• Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS) prior to initiation of opioid treatment

• Patient has a history of loose or watery stools for > 25% of BMs during the 3 months before the Screening in the absence of laxatives, suppositories, or enemas

• Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility

• Patient has any protocol-excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments