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. The Vibrating Capsule was recently shown in a Phase 3 Placebo-Controlled Trial to be effective in treating CIC. The safety and tolerability of the novel Vibrating Capsule system has not been described in detail. METHODS We analyzed data from six trials spanning the development of the Vibrating Capsule, including safety, dose-ranging and pivotal studies. The incidence of adverse events, treatment discontinuation, tolerability and satisfaction were assessed. RESULTS A total of 800 patients from 6 studies were included in this 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 in 11.7% of patients. The rates of these adverse events were low, and most were categorized by the investigators as not related to the treatment. There were no serious adverse events requiring endoscopic or surgical removal of retained capsules and no patients stopped therapy early due to adverse effects. The majority of patients (83%) found the system convenient and the overall satisfaction rate with therapy was 71%. CONCLUSIONS The first in class Vibrating Capsule was found to be safe and well tolerated in clinical trials involving individuals with CIC. No patients discontinued treatment early due to adverse events.