Clinical Trials Logo
  1. Home
  2. Constipation Chronic Idiopathic
  3. NCT05036369

Vibrant Capsule vs. Placebo for Patient Suffering From Constipation — Capsule  

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

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

Clinical Trial Details
NCT number NCT05036369
Study type Interventional
Source Vibrant Ltd.
Contact
Status Completed
Phase N/A
Start date July 5, 2021
Completion date December 15, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT05129618 - Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathic Constipation (CIC) N/A
Suspended NCT04306939 - Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
Recruiting NCT06414525 - Effect of Abdominal Massage Versus Visceral Manipulation on Constipation N/A
Completed NCT06082622 - Evaluation of the Triple Management Program in the Management of Functional Chronic Constipation in Children N/A
Recruiting NCT04148248 - A Pilot Study to Explore the Role of Gut Flora in Chronic Constipation
Active, not recruiting NCT05923723 - Efficacy of a Dietary Intervention for the Treatment of Constipation in Institutionalized Older Adults. Medellín, 2023-2024. N/A
Active, not recruiting NCT06359249 - Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage? N/A
Not yet recruiting NCT06413368 - Maralixibat in Patients With Cystic Fibrosis and Constipation, A Within-Subjects Pilot Study Phase 2/Phase 3
Completed NCT04262752 - MOWOOT Device to Treat Constipation in Adults N/A
Not yet recruiting NCT04666155 - MOWOOT Device Treatment for Adults With Chronic Constipation N/A
Not yet recruiting NCT06349031 - Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction Phase 4