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NCT03879239 · ClinicalTrials.gov registry record · NA
Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation
A NA study of Chronic Idiopathic Constipation, sponsored by Vibrant.
- Completed
- Registry status
- NA
- Development phase
- 349
- Enrollment target
- 8
- Study locations
NCT03879239: Completed NA study of Chronic Idiopathic Constipation, sponsored by Vibrant.
NCT03879239 is a NA study of Chronic Idiopathic Constipation that has completed, run by Vibrant. The registered enrollment target is 349 participants, below the 716-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (51% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03879239, a NA study of Chronic Idiopathic Constipation, has completed, sponsored by Vibrant.
- COMPLETED
- Registry status
- NA
- Development phase
- 349 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
CSBM1Success Rate: defined as the number of subjects with an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment. CSBM2 success rate: defined as the number of subject with 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. The study will be deemed successful if either the CSBM1 or the CSBM2 success rate is s
Conditions Studied
Interventions
- DEVICE Vibrating capsule
Study Locations (8)
Ohio
- Great Lakes Medical Research LLC - Beachwood
- Clinical Inquest Center Ltd - Huber Heights
- Great Lakes Gastroenterology Research - Mentor
Alabama
- G & L Research, LLC. - Foley
Arizona
- Del Sol Research Management - Tucson
Georgia
- Augusta University - Augusta
North Carolina
- PharmQuest - Greensboro
Tennessee
- Clinical Neuroscience Solutions dba CNS Healthcare - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 349 participants |
| Start Date | 2019-04-08 |
| Est. Completion | 2022-01-05 |
| Phase | NA |
What the finished NCT03879239 record still lists
NCT03879239 is an interventional study that assigns participants to a tested intervention. The registered 349 participants enrollment target is mid-sized for trials with a published cap, below the 716-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Chronic Idiopathic Constipation appearing as the primary indexed condition, and to 1 intervention - of which Vibrating capsule is the first listed.
NCT03879239 lists 8 locations in 6 states (Ohio, Alabama, Arizona).
Frequently Asked Questions
What is clinical trial NCT03879239 about?
NCT03879239 is a clinical study titled "Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation". 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.
What is the current status of trial NCT03879239?
This trial is currently completed. It is a NA study. The enrollment target is 349 participants. The study started on 2019-04-08. Estimated completion is 2022-01-05.
What conditions does trial NCT03879239 study?
This clinical trial studies the following conditions: Chronic Idiopathic Constipation.
What interventions are being tested in trial NCT03879239?
The interventions under investigation include: Vibrating capsule (DEVICE).
Who is sponsoring clinical trial NCT03879239?
This trial is sponsored by Vibrant, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03879239 being conducted?
This trial has 8 study locations across Alabama, Arizona, Georgia, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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