NCT05036369

Vibrant Capsule vs. Placebo for Patient Suffering From Constipation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Vibrant Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Constipation Chronic Idiopathic

Interventions

Type	Name	Description
DEVICE	Vibrant capsule	Vibrant capsule - Administered twice a week (Monday and Thursday).
DEVICE	Placebo capsule	Placebo Capsule administered twice a week (Monday and Thursday)

Timeline

• Start date: 2021-07-05
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2021-09-05
• Last updated: 2024-07-09
• Results posted: 2024-07-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study