The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
The study is a prospective, randomized, multicenter, adaptive design, double blinded clinical study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation. Two arms will be assessed (at a ratio of 1:1 of Vibrant Treatment vs. placebo): * Vibrant Capsule administered twice a week (Monday and Thursday) * Placebo Capsule administered twice a week (Monday and Thursday) Subjects will come for 4 visits: Screening (visit 1), baseline (visit 2), after 4 treatment weeks from baseline (visit 3) and after 8 treatment weeks from baseline (Final visit , visit 4). A total of 8 treatment weeks. During the entire study period subjects will be asked to refrain from taking any medications or supplements to relieve their constipation. Subjects will be authorized to use rescue medication after 3 consecutive days without a bowel movement
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Vibrant capsule - Administered twice a week (Monday and Thursday).
Placebo Capsule administered twice a week (Monday and Thursday)
Advanced Rx Clinical Research Group, Inc
Westminster, California, United States
American Research Institute, INC
Cutler Bay, Florida, United States
CSBM 1 Success Rate
CSBM1 Success Rate: defined as the number of Participants 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. NOTE: A spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver. A complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.
Time frame: up to 8 weeks of treatment
CSBM2 Success Rate
CSBM2 Success Rate: defined as the number of Participants 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. NOTE: A spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver. A complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.
Time frame: up to 8 weeks of treatment
Straining Based on the Subject's Assessment Recorded in Daily Diaries
Change from baseline in average straining based on the subject's account in daily diary reports. The straining level reported by the patient on a scale ranged from 0 - No straining to 10 Unbearable straining.
Time frame: up to 10 weeks
CSBM1 Expanded Success Rate,
CSBM1 expanded success rate, defined as the number of Participants with an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 5 of the 8 weeks of treatment.
Time frame: up to 8 weeks of treatment
CSBM2 Expanded Success Rate
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
defined as the number of Participants with an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 5 of the 8 weeks of treatment.
Time frame: up to 8 weeks of treatment
Change From Baseline in Stool Consistency
Change from baseline in average stool consistency, using the Bristol Stool Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass) and 7 =watery, no solid pieces, entirely liquid
Time frame: up to 10 weeks