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
Status: | Completed |
---|---|
Conditions: | Constipation |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2014 |
End Date: | October 2015 |
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered Orally for 8 Weeks to Adult Outpatients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain
The purpose of this study is 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 includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period.
Patients meeting the entry criteria will be randomized to 1 of 2 doses of linaclotide or
placebo for 8 weeks. This 8-week study will assess the effects of linaclotide on bowel
movement frequency, as well as other bowel symptoms of OIC.
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 includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period.
Patients meeting the entry criteria will be randomized to 1 of 2 doses of linaclotide or
placebo for 8 weeks. This 8-week study will assess the effects of linaclotide on bowel
movement frequency, as well as other bowel symptoms of OIC.
Inclusion Criteria:
- Patient has chronic non-cancer pain that has been present for a minimum of 3 months
- Patient has been receiving a stable 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
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
We found this trial at
78
sites
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