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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
254
Matching placebo
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
Change From Baseline in 8-Week SBM Frequency Rate (SBMs/Week)
Change from baseline in 8-Week SBM frequency rate (SBMs/week) during the Treatment Period.
Time frame: Baseline (Week 0) to Week 8
Time to First SBM After the First Dose of Investigational Product
The median time to the first SBM after the first dose of investigational product
Time frame: Baseline (Day 0) up to 8 weeks
Percentage of Participants Meeting 6/8 Week Spontaneous Bowel Movement (SBM) 3 + 1 Responder Criteria
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.
Time frame: 8-week treatment period
Change From Baseline in 8-Week Stool Consistency
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)
Time frame: Baseline (Week 0) to Week 8
Change From Baseline in 8-Week Straining
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."
Time frame: Baseline (Week 0) to Week 8
Change From Baseline in 8-Week Abdominal Bloating
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.
Time frame: Baseline (Week 0) to Week 8
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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
...and 67 more locations