A Prospective, Randomized, Multi-center, Single-Blinded, Placebo-Controlled, 3-Arm Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule, for the Treatment of Chronic Idiopathic Constipation

Investigator: Eamonn Quigley, MD

Study Coordinator: DeAndrea Hester

Status: Enrolling

ClinicalTrials.gov Number: NCT03879239

Phone: 281.485.3434

Protocol Number: Pro00021535

Description

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