A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week
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|ClinicalTrials.gov Identifier: NCT03031301|
Recruitment Status : Unknown
Verified January 2018 by Vibrant Ltd..
Recruitment status was: Recruiting
First Posted : January 25, 2017
Last Update Posted : January 12, 2018
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation.
Two arms will be assessed:
- Vibrant Capsule administered 5 times per week
- Sham Capsule administered 5 times per week
Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 8 weeks.
Data reporting will be done on an electronic Case Report Form (eCRF) and an eDiary.
Subjects will be asked to refrain from taking any medication or supplement to relieve their constipation, during the entire study period.
After the 14 days of run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be trained on how to use the base unit and will swallow the first capsule on site the day of baseline visit. They will activate and ingest the rest of the capsules at home by themselves, using the base unit.
Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study. A final visit will take place at the end of the 8 week treatment period.
Subjects will receive phone calls at least once a week and subject compliance will be monitored during the 8 weeks of the study.
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Device: Vibrant capsule Device: Sham capsule||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Active Comparator: Vibrant capsule
Patients will receive the Vibrant capsule 5 times a week for 8 weeks of treatment
Device: Vibrant capsule
One Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment.
Sham Comparator: Sham capsule
Patients will receive the sham capsule (activated, non-vibrating) 5 times a week for 8 weeks of treatment
Device: Sham capsule
One Sham capsule will be ingested 5 times per week for 8 weeks of treatment.
- Complete Spontaneous Bowel Movement (CSBM) success rate, defined as an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment. [ Time Frame: 8 weeks ]Complete Spontaneous Bowel Movements
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031301
|Contact: Dvora Darkyfirstname.lastname@example.org|
|Contact: Lior Ben Tsur|
|United States, Alabama|
|Guntersville, Alabama, United States, 35976|
|Contact: Cynthia Abath|
|Principal Investigator: William A Nixon, MD|
|United States, Florida|
|Floridian Research Institute||Recruiting|
|Miami, Florida, United States, 33145|
|Contact: Milene Garcia|
|Principal Investigator: Jorge Loredo, MD|