NCT03879239

Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation

A Prospective, Randomized, Multi-center, Double-Blinded, Placebo-Controlled, 3-Arm Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule, for the Treatment of Chronic Idiopathic Constipation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: Vibrant Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, randomized, multicenter, adaptive design, double blinded, placebo-controlled study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.

Detailed description

Subjects came for 4 visits: Screening (visit 1), baseline (visit 2), after 4 treatment weeks from baseline (visit 3) and after 8 treatment weeks from baseline (Final visit , visit 4). A total of 8 treatment weeks Three arms were assessed: * Vibrant Capsule mode A administered 5 times per week * Vibrant Capsule mode B administered 5 times per week * Placebo Capsule administered 5 times per week The difference between the 2 operating modes is in the vibrating sequence during the capsule's operating time. Following Interim Analysis one active arm was dropped and the study continued with 2 arms, placebo and an active arm.

Conditions

• Chronic Idiopathic Constipation

Interventions

Type	Name	Description
DEVICE	Vibrating capsule	Vibrating Capsule administered 5 times per week

Timeline

• Start date: 2019-04-08
• Primary completion: 2021-07-16
• Completion: 2022-01-05
• First posted: 2019-03-18
• Last updated: 2024-08-09
• Results posted: 2024-08-09

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study