Constipation Clinical Trial
Official title:
A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled
pilot study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving
constipation in subjects with functional constipation.
Three arms will be assessed:
- Vibrant Capsule with vibrating mode 1 administered 5 times per week
- Vibrant Capsule with vibrating mode 2 administered 5 times per week
- Sham Capsule administered 5 times per week
Subjects will be followed continuously for at least a 2 weeks run-in period and then be
randomized to either Vibrant or Sham capsules for a treatment period of 8 weeks. The first 2
weeks of treatment will be considered as a subjects' training period.
Data reporting will be done on an electronic Case Report Form 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 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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