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Clinical Trial Summary

The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05036369
Study type Interventional
Source Vibrant Ltd.
Contact Dvora Darky
Phone +97246.6660885
Email [email protected]
Status Recruiting
Phase N/A
Start date July 5, 2021
Completion date August 30, 2022

See also
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Completed NCT04262752 - MOWOOT Device to Treat Constipation in Adults N/A