Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)

For each week of the Treatment and Posttreatment Periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥ 4 days of IVRS questions, 2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from the baseline weekly CSBM rate.

Time frame: Change from Baseline to Week 12

Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period

SBMs were measured daily during the treatment period by patient calls to the IVRS.

Time frame: Change from Baseline to Week 12

Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period

Stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 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 stool; and 7 = watery, no solid pieces (entirely liquid).

Time frame: Change from Baseline to Week 12

Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period