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

Completed · Phase 2 · Has a placebo group

Conditions studied: Opioid-Induced Constipation

In brief

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.

Key facts

Study ID

NCT02270983

Run by

Forest Laboratories

People needed

254

Starts

2014-10-31

Expected to finish

2015-10-31

Last updated by the study team

2019-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Straining during > 25% of BMs
• Lumpy or hard stools during > 25% of BMs
• 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

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 001 — Foley, Alabama, United States
• Forest Investigative Site 007 — Phoenix, Arizona, United States
• Forest Investigative Site 008 — Tucson, Arizona, United States
• Forest Investigative Site 003 — North Little Rock, Arkansas, United States
• Forest Investigative Site 018 — Anaheim, California, United States
• Forest Investigative Site 014 — Fountain Valley, California, United States
• Forest Investigative Site 019 — Fresno, California, United States
• Forest Investigative Site 017 — Garden Grove, California, United States
• Forest Investigative Site 010 — Gold River, California, United States
• Forest Investigative Site 009 — Lincoln, California, United States
• Forest Investigative Site 012 — North Hollywood, California, United States
• Forest Investigative Site 011 — Orange, California, United States
• Forest Investigative Site 016 — Sacramento, California, United States
• Forest Investigative Site 013 — San Diego, California, United States
• Forest Investigative Site 015 — Santa Ana, California, United States
• Forest Investigative Site 020 — Colorado Springs, Colorado, United States
• Forest Investigative Site 021 — Bristol, Connecticut, United States
• Forest Investigative Site 035 — Boynton Beach, Florida, United States
• Forest Investigative Site 038 — Bradenton, Florida, United States
• Forest Investigative Site 024 — DeLand, Florida, United States
• Forest Investigative Site 027 — Gainesville, Florida, United States
• Forest Investigative Site 023 — Jacksonville, Florida, United States
• Forest Investigative Site 036 — Jupiter, Florida, United States
• Forest Investigative Site 037 — Lauderdale Lakes, Florida, United States
• Forest Investigative Site 002 — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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