@article{cb9830bd027d48c09ed110ce5fcc31a8,
title = "Randomized Placebo-Controlled Phase 3 Trial of Vibrating Capsule for Chronic Constipation",
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).",
keywords = "Bowel Symptoms, Constipation, Quality of Life, Treatment, Vibrating Capsule, Constipation/diagnosis, Double-Blind Method, Humans, Treatment Outcome, Defecation",
author = "Rao, {Satish S.C.} and Quigley, {Eamonn M.M.} and Chey, {William D.} and Amol Sharma and Lembo, {Anthony J.}",
note = "Funding Information: Conflicts of interest Satish S.C. Rao serves on the scientific advisory board of Vibrant Ltd and received research grant support for conducting this trial. He also served as a consultant for Sanofi Pharmaceuticals, Salix Pharmaceuticals, Laborie Ltd, Ardelyx pharmaceuticals, Restalsis, and Abbvie pharmaceuticals. Eamonn M.M. Quigley has served on the scientific advisory board of Vibrant Ltd and as an advisor and consultant to 4D Pharma, Axon Pharma, Biocodex, Novozymes , Precisionbiotics, Salix pharmaceuticals, and Vibrant Ltd and has received research support from 4D Pharma , Biomerica , Takeda , and Vibrant Ltd . William Chey has served as a scientific consultant to Vibrant Ltd, Abbvie, Allakos, Alnylam, Ardelyx, Arena, Bayer, Biomerica, Ironwood, Nestle, QOL Medical, Salix/Valeant, Takeda Pharmaceuticals, and Urovant Sciences. Amol Sharma received grant support from Vibrant Ltd, and served on the advisory board for Ironwood Pharmaceuticals , Salix Pharmaceuticals , Takeda Pharmaceuticals , and Phanthom Pharmaceuticals . Anthony J. Lembo has served as scientific consultant for Vibrant Ltd., Allakos, Ardelyx, Arena, Bayer, BioAmerica, Ironwood, QOL Medical, Salix/Valeant, Takeda pharmaceuticals, Mauea Kae Technology, and Gemelli. Funding Information: Conflicts of interest Satish S.C. Rao serves on the scientific advisory board of Vibrant Ltd and received research grant support for conducting this trial. He also served as a consultant for Sanofi Pharmaceuticals, Salix Pharmaceuticals, Laborie Ltd, Ardelyx pharmaceuticals, Restalsis, and Abbvie pharmaceuticals. Eamonn M.M. Quigley has served on the scientific advisory board of Vibrant Ltd and as an advisor and consultant to 4D Pharma, Axon Pharma, Biocodex, Novozymes, Precisionbiotics, Salix pharmaceuticals, and Vibrant Ltd and has received research support from 4D Pharma, Biomerica, Takeda, and Vibrant Ltd. William Chey has served as a scientific consultant to Vibrant Ltd, Abbvie, Allakos, Alnylam, Ardelyx, Arena, Bayer, Biomerica, Ironwood, Nestle, QOL Medical, Salix/Valeant, Takeda Pharmaceuticals, and Urovant Sciences. Amol Sharma received grant support from Vibrant Ltd, and served on the advisory board for Ironwood Pharmaceuticals, Salix Pharmaceuticals, Takeda Pharmaceuticals, and Phanthom Pharmaceuticals. Anthony J. Lembo has served as scientific consultant for Vibrant Ltd., Allakos, Ardelyx, Arena, Bayer, BioAmerica, Ironwood, QOL Medical, Salix/Valeant, Takeda pharmaceuticals, Mauea Kae Technology, and Gemelli. Funding Supported by Vibrant Ltd. Publisher Copyright: {\textcopyright} 2023",
year = "2023",
month = jun,
doi = "10.1053/j.gastro.2023.02.013",
language = "English (US)",
volume = "164",
pages = "1202--1210.e6",
journal = "Gastroenterology",
issn = "0016-5085",
publisher = "W.B. Saunders Ltd",
number = "7",
}