NCT03031301

A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week

A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Vibrant Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation. Two arms will be assessed: * Vibrant Capsule administered 5 times per week * Sham Capsule administered 5 times per week

Detailed description

The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation. Two arms will be assessed: * Vibrant Capsule administered 5 times per week * Sham Capsule administered 5 times per week Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 8 weeks. Data reporting will be done on an electronic Case Report Form (eCRF) and an eDiary. Subjects will be asked to refrain from taking any medication or supplement to relieve their constipation, during the entire study period. After the 14 days of run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be trained on how to use the base unit and will swallow the first capsule on site the day of baseline visit. They will activate and ingest the rest of the capsules at home by themselves, using the base unit. Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study. A final visit will take place at the end of the 8 week treatment period. Subjects will receive phone calls at least once a week and subject compliance will be monitored during the 8 weeks of the study.

Conditions

• Constipation

Interventions

Type	Name	Description
DEVICE	Vibrant capsule	One Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment.
DEVICE	Sham capsule	One Sham capsule will be ingested 5 times per week for 8 weeks of treatment.

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-07-30
• Completion: 2018-07-30
• First posted: 2017-01-25
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study