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Clinical Trial Summary

The study is a prospective, randomized, multicenter, adaptive design, double blinded, placebo-controlled study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.


Clinical Trial Description

Subjects came 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 Three arms were assessed: - Vibrant Capsule mode A administered 5 times per week - Vibrant Capsule mode B administered 5 times per week - Placebo Capsule administered 5 times per week The difference between the 2 operating modes is in the vibrating sequence during the capsule's operating time. Following Interim Analysis one active arm was dropped and the study continued with 2 arms, placebo and an active arm. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03879239
Study type Interventional
Source Vibrant Ltd.
Contact
Status Completed
Phase N/A
Start date March 30, 2019
Completion date January 5, 2022

See also
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