Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-05 @ 2:13 AM
Study NCT ID:
NCT05036369
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2021-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vibrant Capsule vs. Placebo for Patient Suffering From Constipation
Sponsor:
Vibrant Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Multi-center, Double-Blinded, Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule vs. Placebo, for the Treatment of Chronic Idiopathic Constipation
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Capsule
Brief Summary:
The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week
Detailed Description:
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: