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Vibrant capsule for Chronic Constipation (Capsule 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 up to 10 weeks
Awards & highlights
Capsule Trial Summary
This trial is testing a new capsule that is taken twice a week to see if it is safe and effective.
Eligible Conditions
- Chronic Constipation
Capsule Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CSBM 1 success rate: Increase of at least one Complete Spontaneous Bowel Movement (CSBM) a week from BL.
Increase of at least two Complete Spontaneous Bowel Movement (CSBM) a week from BL
adverse events
Secondary outcome measures
Bloating based on the subject's assessment recorded in daily diaries (Scale ranged from 0- No bloating to 10 Unbearable bloating)
CSBM1 expanded success rate
CSBM2 expanded success rate
+1 moreCapsule Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active capsuleExperimental Treatment1 Intervention
The Vibrant non-biodegradable capsule administrated twice a week
Group II: PlaceboPlacebo Group2 Interventions
The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vibrant capsule
2021
Completed Phase 4
~190
Find a Location
Who is running the clinical trial?
Vibrant Ltd.Lead Sponsor
9 Previous Clinical Trials
903 Total Patients Enrolled
Dvora DarkyStudy DirectorVibrant Ltd.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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