Tolerability, Safety and Efficacy of a New Frequency of Vibrant Capsule Administration
- Conditions
- Constipation
- Interventions
- Device: Vibrating Capsule
- Registration Number
- NCT02829047
- Lead Sponsor
- Vibrant Ltd.
- Brief Summary
The study is a prospective, multicenter, open-label, single-arm study, to evaluate the tolerability, safety and efficacy of the Vibrant Capsule in relieving constipation.
- Detailed Description
One arm will be assessed: Vibrant Capsule administered with a sequence of one per day for 2 days, followed by one day without, one per day for 2 days followed by one day without, etc. (14 capsules in 3 weeks).
The study will have one interim analysis.
Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 6 weeks.
Data reporting will be done on an electronic Case Report Form and an eDiary. During the 2 weeks of baseline, patients will be asked to refrain from taking any medication or supplement to relieve their constipation.
After 14 days the patients will return and eligibility will be re-assessed. Patients will be trained on how to use the base unit.
Patients will be instructed to complete a simple patient eDiary each day throughout the duration of the study. After 3 weeks of treatment, the patient will attend for evaluation and to receive new capsules. A final visit will take place at the end of the 6 week treatment period.
Patients will receive phone calls up to twice per week and patient compliance will be monitored during the 8 weeks of the study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vibrating Capsule Vibrating Capsule Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks)
- Primary Outcome Measures
Name Time Method Spontaneous Bowel Movements Success Rate 6 weeks of treatment Defined as the number of subjects with an increase from the run-in period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 3 of the 6 weeks of treatment. Subjects with less than 2 weeks (with at least 5 days per week) of valid diary during the treatment period will be considered as non-evaluable.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Avant Guntersville
🇺🇸Guntersville, Alabama, United States
Floridian Research Institute
🇺🇸Miami, Florida, United States
Albuquerque Neuroscience
🇺🇸Albuquerque, New Mexico, United States