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Clinical Trial Summary

The study is a prospective, open-label, single-arm study, to evaluate the ease of use, tolerability, efficacy and safety of the Vibrant Capsule administered in the home environment.

One arm will be assessed: Vibrant Capsule administered twice a week.

Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 6 weeks.

During the 2 weeks of baseline, patients will be asked to refrain from taking any medication or supplement to relieve their constipation.

After 14 days the patients will return and eligibility will be re-assessed. Patients will be instructed to complete a simple patient eDiary each day throughout the duration of the study. After 3 weeks of treatment, the patient will attend for evaluation and to receive new capsules. A final visit will take place at the end of the 6 week treatment period.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02895516
Study type Interventional
Source Vibrant Ltd.
Contact
Status Withdrawn
Phase Phase 2
Start date October 2016
Completion date May 2017

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