Status:
COMPLETED
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
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Ironwood Pharmaceuticals, Inc.
Conditions:
Opioid-Induced Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-can...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2015
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT02270983
Start Date
October 31 2014
End Date
October 31 2015
Last Update
April 8 2019
Active Locations (77)
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1
Forest Investigative Site 002
Anniston, Alabama, United States, 36207
2
Forest Investigative Site 001
Foley, Alabama, United States, 36535
3
Forest Investigative Site 007
Phoenix, Arizona, United States, 85029
4
Forest Investigative Site 008
Tucson, Arizona, United States, 85710