At a glance
ClinicalIndex Comparison RecordN/ACompleted· 182 enrolled
Drug / intervention
Vibrant capsule +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week
In Brief
A clinical study evaluating Vibrant capsule and Sham capsule for Constipation. Completed, enrolled 182 participants across 2 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartFeb 2017
Primary CompletionJul 2018
TodayJul 2026
First PostedJan 25, 2017
Enrollment StartFeb 1, 2017
Primary CompletionJul 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.4 years ago
Interventions
Vibrant capsuledevice
One Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment.
Sham capsuledevice
One Sham capsule will be ingested 5 times per week for 8 weeks of treatment.