LAUSR

BACKGROUND & AIMS Despite therapeutic advances, effective treatments for chronic constipation remain an unmet need. The vibrating capsule is a non-pharmacologic, orally-ingested, programmable capsule that vibrates intraluminally to induce bowel movements. We aimed to determine the efficacy and safety of vibrating capsule in patients with chronic constipation. METHODS We conducted a phase 3, double-blind, placebo-controlled trial of patients with chronic constipation, who were randomized to receive either a vibrating or placebo capsule, once daily, five days a week for 8 weeks. The primary efficacy end points were an increase of one or more complete spontaneous bowel movements per week (CSBM1 responder) or two or more CSBMs per week (CSBM2) from baseline during at least 6 of the 8 weeks. Safety analyses were performed. RESULTS Among 904 patients screened, 312 were enrolled. A greater percentage of patients receiving the vibrating capsule achieved both primary efficacy end points compared to placebo (39.3% vs. 22.1%, p=0.001 for CSBM1; 22.7% vs. 11.4% p=0.008 for CSBM2). Significantly greater improvements were seen with the vibrating capsule for the secondary end points of straining, stool consistency, and quality of life measures compared to placebo. Adverse events were mild, gastrointestinal in nature and similar between groups, except that a mild vibrating sensation was reported by 11% of patients in the vibrating capsule group, but none withdrew from the trial. CONCLUSIONS In patients with chronic constipation, the vibrating capsule was superior to placebo in improving bowel symptoms and quality of life. The vibrating capsule was safe and well tolerated.