The Vibrating Capsule: Safety and Tolerability in Patients With Chronic Idiopathic Constipation.

Abstract

Background: Chronic idiopathic constipation (CIC) remains a significant problem globally with increasing estimates for disease burden. In a Phase 3 placebo-controlled trial, a novel treatment using the Vibrating Capsule was recently shown to be effective in treating patients with CIC. However, its safety and tolerability has not been described in detail.

Methods: We analyzed safety data from six trials encompassing the development of the Vibrating Capsule, including, dose-ranging and pivotal studies. The incidence of adverse events, treatment discontinuation, tolerability and satisfaction were assessed.

Key results: A total of 800 patients who took either an active Vibrating Capsule or a sham/placebo (non-vibrating) but similar capsule from 6 studies were included in this post hoc analysis. The most common adverse gastrointestinal events were bloating (2.9%), abdominal pain (2.9%), nausea (2.3%) and diarrhea (1.9%). A sensation of vibration was reported by 11.7% of patients. The adverse events rates were low, and investigators categorized most of them as unrelated to treatment. There were no serious adverse events such as retention of therapeutic capsules and no patient stopped therapy or withdrew due to adverse effects. The majority of patients (83%) found the system convenient, with an overall treatment satisfaction rate of 71%.

Conclusions and inferences: The Vibrating Capsule, a first in class treatment for CIC was found to be safe and well tolerated by patients in clinical trials. No patient discontinued treatment due to adverse events.