An interventional study of vibrating capsule and sham non-vibrating capsule in Chronic Idiopathic Constipation, sponsored by Vibrant Ltd.. Completed at 18 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-07.
Sponsored by Vibrant Ltd. · Not applicable, Interventional, and Treatment
This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 144 is above the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Vibrant Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-
patients will receive vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
Device: vibrating capsule
patients will receive sham non-vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
Device: sham non-vibrating capsule
patients will receive vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
patients will receive sham non-vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
Frequency of bowel movements
change from baseline in the weekly Spontaneous Bowel Movement (SBM) rate during treatment period. Success will be defined as increase by at least 1 SBM/week. The primary analysis will be a comparative analysis of success rates between the study groups
Time frame: 3 months
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vibrant Ltd.