Constipation Clinical Trial
Official title:
A Prospective, Open-label, Single-arm Study to Assess the Ease of Use, Tolerability, Efficacy and Safety of the Vibrant Capsule Administered in the Home Environment.
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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