LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).1
Based on responses to the following questions: How would you rate your worst abdominal bloating, your worst abdominal discomfort, and your worst abdominal pain in the past 24 hours?
*P<0.0001 for the 11.4% difference between placebo and linaclotide from baseline to Week 12.
STUDY DESIGN: A randomized, double-blind, placebo-controlled, parallel-group study (N=600, 300 per arm) to evaluate the efficacy on overall combined abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 mcg administered orally to patients with irritable bowel syndrome with predominant constipation (IBS-C). The study comprised a 12-week treatment period and a 4-week randomized withdrawal period (post-treatment). The primary endpoint was numeric change from baseline in overall abdominal symptom score obtained each week via patient eDiary entries, calculated by combining daily patient assessments from three 11-point scales (1 scale/score for each symptom) obtained daily, and averaged weekly over the study period.
Change from Baseline in Bloating
Change from Baseline in Discomfort
Change from Baseline in Pain