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.
Subjects came 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 Three arms were assessed: * Vibrant Capsule mode A administered 5 times per week * Vibrant Capsule mode B administered 5 times per week * Placebo Capsule administered 5 times per week The difference between the 2 operating modes is in the vibrating sequence during the capsule's operating time. Following Interim Analysis one active arm was dropped and the study continued with 2 arms, placebo and an active arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
349
Vibrating Capsule administered 5 times per week
G & L Research, LLC.
Foley, Alabama, United States
Del Sol Research Management
Tucson, Arizona, United States
Augusta University
Augusta, Georgia, United States
PharmQuest
Greensboro, North Carolina, United States
CSBM1 & CSBM2 Success Rate
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 statistically significantly higher in the active arm that was continued after the interim analysis (Vibrant Capsule Mode A), than in the placebo arm 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: 8 weeks of treatment
Change From Baseline in Average Straining
Change from baseline in average straining using (0-10) scale where "0" is no straining and "10" is unbearable straining
Time frame: 8 weeks of treatment
Change From Baseline in Average 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: 8 weeks of treatment
Change From Baseline in Average Bloating
Change from baseline in average bloating using scale (0-10) for bloating where 0=No bloating and 10=Unbearable bloating
Time frame: 8 weeks of treatment
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Great Lakes Medical Research LLC
Beachwood, Ohio, United States
Clinical Inquest Center Ltd
Huber Heights, Ohio, United States
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Mentor, Ohio, United States
Clinical Neuroscience Solutions dba CNS Healthcare
Memphis, Tennessee, United States