Randomized Placebo-Controlled Phase 3 Trial of Vibrating Capsule for Chronic Constipation

Satish S.C. Rao, Eamonn M.M. Quigley, William D. Chey, Amol Sharma, Anthony J. Lembo

Research output: Contribution to journalArticlepeer-review

23 Scopus citations

Abstract

BACKGROUND & AIMS: Despite therapeutic advances, effective treatments for chronic constipation remain an unmet need. The vibrating capsule is a nonpharmacologic, orally ingested, programmable capsule that vibrates intraluminally to induce bowel movements. We aimed to determine the efficacy and safety of the 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, 5 days a week for 8 weeks. The primary efficacy end points were an increase of 1 or more complete spontaneous bowel movements per week (CSBM 1 responder) or 2 or more CSBMs per week (CSBM 2) 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 with placebo (39.3% vs 22.1%, P = .001 for CSBM 1; 22.7% vs 11.4% P = .008 for CSBM 2). Significantly greater improvements were seen with the vibrating capsule for the secondary end points of straining, stool consistency, and quality-of-life measures compared with 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. (Clinical trials.gov, Number: NCT03879239).

Original languageEnglish (US)
Pages (from-to)1202-1210.e6
JournalGastroenterology
Volume164
Issue number7
DOIs
StatePublished - Jun 2023

Keywords

  • Bowel Symptoms
  • Constipation
  • Quality of Life
  • Treatment
  • Vibrating Capsule
  • Constipation/diagnosis
  • Double-Blind Method
  • Humans
  • Treatment Outcome
  • Defecation

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

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