Constipation Chronic Idiopathic Clinical Trial
Official title:
A Prospective, Randomized, Multi-center, Double-Blinded, Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Placebo, for the Treatment of Chronic Idiopathic Constipation
The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
The study is a prospective, randomized, multicenter, adaptive design, double blinded clinical study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation. Two arms will be assessed (at a ratio of 1:1 of Vibrant Treatment vs. placebo): - Vibrant Capsule administered twice a week (Monday and Thursday) - Placebo Capsule administered twice a week (Monday and Thursday) Subjects will come for 4 visits: Screening (visit 1), baseline (visit 2), after 4 treatment weeks from baseline (visit 3) and after 8 treatment weeks from baseline (Final visit , visit 4). A total of 8 treatment weeks. During the entire study period subjects will be asked to refrain from taking any medications or supplements to relieve their constipation. Subjects will be authorized to use rescue medication after 3 consecutive days without a bowel movement ;
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