DRUG
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
Phase
Phase 2
Enrollment
254
Locations
77
Results
Posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Linaclotide 290 micrograms
DRUG
Placebo
Matching placebo
Timeline
From registration to results.
First posted
Oct 22, 2014
Study start
Oct 31, 2014
Primary completion
Aug 31, 2015
Study completion
Oct 31, 2015
Results posted
Apr 8, 2019
Registry updated
Apr 8, 2019
Outcomes
What the study measures.
Primary outcomes
Change From Baseline in 8-Week SBM Frequency Rate (SBMs/Week)
Time frame · Baseline (Week 0) to Week 8
Change from baseline in 8-Week SBM frequency rate (SBMs/week) during the Treatment Period.
Secondary outcomes
Time to First SBM After the First Dose of Investigational Product
Time frame · Baseline (Day 0) up to 8 weeks
The median time to the first SBM after the first dose of investigational product
Percentage of Participants Meeting 6/8 Week Spontaneous Bowel Movement (SBM) 3 + 1 Responder Criteria
Time frame · 8-week treatment period
A 6/8 Week SBM 3 + 1 responder was a participant who met the weekly SBM 3 + 1 responder criteria for at least 6 out of the 8 weeks of the Treatment Period. For each week in the Treatment Period, a weekly SBM 3 + 1 responder was a patient who had an SBM weekly rate ≥ 3 and an increase ≥ 1 in the SBM weekly rate from baseline for that week.
Change From Baseline in 8-Week Stool Consistency
Time frame · Baseline (Week 0) to Week 8
Stool Consistency was assessed using the 7-Point Bristol Stool Form Scale: 1. = separate hard lumps like nuts (difficult to pass) 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges (passed easily) 6. = fluffy pieces with ragged edges, a mushy 7. = watery, no solid pieces (entirely liquid)
Change From Baseline in 8-Week Straining
Time frame · Baseline (Week 0) to Week 8
Straining was measured on a 5-point ordinal scale where a value of 1 is "not at all" and a value of 5 is "an extreme amount."
Change From Baseline in 8-Week Abdominal Bloating
Time frame · Baseline (Week 0) to Week 8
Abdominal bloating was collected daily via IVRS calls and measured using an 11-point numerical rating scale, where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 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
Study locations
77 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Forest Investigative Site 002
Anniston, Alabama, United States
Forest Investigative Site 001
Foley, Alabama, United States
Forest Investigative Site 007
Phoenix, Arizona, United States
Forest Investigative Site 008
Tucson, Arizona, United States
Forest Investigative Site 003
North Little Rock, Arkansas, United States
Forest Investigative Site 018
Anaheim, California, United States
Forest Investigative Site 014
Fountain Valley, California, United States
Forest Investigative Site 019
Fresno, California, United States
Forest Investigative Site 017
Garden Grove, California, United States
Forest Investigative Site 010
Gold River, California, United States
Forest Investigative Site 009
Lincoln, California, United States
Forest Investigative Site 012
North Hollywood, California, United States
Forest Investigative Site 011
Orange, California, United States
Forest Investigative Site 016
Sacramento, California, United States
Forest Investigative Site 013
San Diego, California, United States
Forest Investigative Site 015
Santa Ana, California, United States
Forest Investigative Site 020
Colorado Springs, Colorado, United States
Forest Investigative Site 021
Bristol, Connecticut, United States
Forest Investigative Site 035
Boynton Beach, Florida, United States
Forest Investigative Site 038
Bradenton, Florida, United States
Forest Investigative Site 024
DeLand, Florida, United States
Forest Investigative Site 027
Gainesville, Florida, United States
Forest Investigative Site 023
Jacksonville, Florida, United States
Forest Investigative Site 036
Jupiter, Florida, United States
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Related PeptideStat pages
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