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
Opioid-Induced Constipation
About this trial
This is an interventional treatment trial for Opioid-Induced Constipation focused on measuring Opioid-Induced Constipation, Linaclotide, Linzess
Eligibility 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:
- 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 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
Sites / Locations
- Forest Investigative Site 002
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Linaclotide 145 micrograms
Linaclotide 290 micrograms
Placebo
Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.