Constipation Clinical Trial
Official title:
A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week
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.
n/a
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