Constipation Clinical Trial
Official title:
A Prospective, Multicenter, Open-label, Single-arm Study to Assess the Tolerability, Safety and Efficacy of a New Frequency of Vibrant Capsule Administration
The study is a prospective, multicenter, open-label, single-arm study, to evaluate the
tolerability, safety and efficacy of the Vibrant Capsule in relieving constipation.
One arm will be assessed: Vibrant Capsule administered with a sequence of one per day for 2
days, followed by one day without, one per day for 2 days followed by one day without, etc.
(14 capsules in 3 weeks).
The study will have one interim analysis.
Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a
treatment period of 6 weeks.
Data reporting will be done on an electronic Case Report Form and an eDiary. 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
trained on how to use the base unit.
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.
Patients will receive phone calls up to twice per week and patient compliance will be
monitored during the 8 weeks of the study.
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