This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand. The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,722
matching Placebo Capsules, Oral, once daily
Linaclotide 290 ug Capsules, Oral, once daily
Research Site
Huntsville, Alabama, United States
Research Site
North Little Rock, Arkansas, United States
Research Site
Phoenix, Arkansas, United States
Research Site
Artesia, California, United States
Research Site
Chula Vista, California, United States
Research Site
12-week Abdominal Pain/Abdominal Discomfort Weekly Responder
A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period. Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain. Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
Time frame: Baseline and Weeks 1-12 during the Treatment Period
12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder
A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was "Considerably relieved" or "Completely relieved") for at least 6 out of the 12 weeks of the Treatment Period. Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine.
Time frame: Baseline and Weeks 1-12 during the Treatment Period
Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate
The change from baseline in 12-week CSBM frequency (i.e., average weekly CSBM frequency over the 12 weeks of the Treatment Period). A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as an SBM that is associated with a sense of complete evacuation.
Time frame: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate
The change from baseline in 12-week SBM frequency (i.e., average weekly SBM frequency over the 12 weeks of the Treatment Period). SBM is defined as a bowel movement without laxative use in the preceding 24 hours.
Time frame: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Stool Consistency
The change from baseline in 12-week stool consistency (i.e., the average of the non-missing Bristol Stool Form Scale \[BSFS\] score from the SBMs occurring during the 12-week Treatment Period). Consistency of each bowel movement was assessed daily by patients using the 7-point BSFS (1=Separate hard lumps like nuts \[difficult to pass\] to 7=Watery, no solid pieces \[entirely liquid\]).
Time frame: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Severity of Straining
The change from baseline in 12-week severity of straining (i.e., the average of the non-missing straining scores from the SBMs occurring during the 12-week Treatment Period). Severity of straining was assessed daily by patients on a 5-point ordinal scale (1=Not at all to 5=An extreme amount).
Time frame: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Abdominal Bloating
The change from baseline in 12-week abdominal bloating (i.e., the average of the non-missing daily abdominal bloating scores reported during the 12-week Treatment Period). Abdominal bloating (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating.
Time frame: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Abdominal Pain
The change from baseline in 12-week abdominal pain (i.e., the average of the non-missing daily abdominal pain scores reported during the 12-week Treatment Period). Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Time frame: Baseline and 12-week Treatment Period
Change From Baseline in 12-week Abdominal Discomfort
The change from baseline in 12-week abdominal discomfort (i.e., the average of the non-missing daily abdominal discomfort scores reported during the 12-week Treatment Period). Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
Time frame: Baseline and 12-week Treatment Period
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Encino, California, United States
Research Site
North Hollywood, California, United States
Research Site
Orange, California, United States
Research Site
Riverside, California, United States
Research Site
San Diego, California, United States
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