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Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation (Vibrant Trial)
N/A
Waitlist Available
Research Sponsored by Vibrant Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks of treatment
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.
Eligible Conditions
- Chronic Constipation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CSBM1 & CSBM2 Success Rate
Secondary study objectives
Change From Baseline in Average Bloating
Change From Baseline in Average Stool Consistency
Change From Baseline in Average Straining
Other study objectives
Change From Baseline in Quality of Life
Change in SBM
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Vibrant Capsule mode AActive Control1 Intervention
Vibrant Capsule mode A administered 5 times per week
Group II: Vibrant Capsule mode BActive Control1 Intervention
Vibrant Capsule mode B administered 5 times per week.
Based on the analysis of the first pre-define phase of the study, active mode B was discontinued, and the trial was completed using mode A. Therefore, study results are not available for arm B.
Group III: Placebo CapsulePlacebo Group1 Intervention
Placebo Capsule administered 5 times per week
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Who is running the clinical trial?
Vibrant Ltd.Lead Sponsor
9 Previous Clinical Trials
627 Total Patients Enrolled
Tal Malina, MBAStudy DirectorVibrant Ltd.
1 Previous Clinical Trials
100 Total Patients Enrolled