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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Forest Laboratories
With
Ironwood Pharmaceuticals, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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:
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
You may not be 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
Clareo Health | 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
