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Opioid-Induced Constipation

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

Sponsored by Forest Laboratories

About this trial

Last updated 6 years ago

Study ID

LIN-MD-40

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 10 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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