NCT03031301

A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week

Completed NA Results posted Last updated 3 July 2024

What this trial tests

NA trial testing Vibrant capsule in Constipation in 182 participants. Completed in 30 July 2018.

Timeline

1 February 2017

Primary endpoint
30 July 2018

30 July 2018

Quick facts

Lead sponsor	Vibrant Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	182
Start date	1 February 2017
Primary completion	30 July 2018
Estimated completion	30 July 2018
Sites	2 locations across United States

Drugs / interventions tested

• Vibrant capsule
• Sham capsule

Conditions studied

• Constipation — all drugs for Constipation →

Sponsor

Vibrant Ltd.

Who can join

22 and older, any sex, with Constipation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

CSBM1- Number of Participants With an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment Primary · 8 weeks

CSBM1 success rate, defined as 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

Group	Value	95% CI
Vibrant Capsule	24
Sham Capsule	33

CSBM2- Number of Participants With an Increase of at Least 2 Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment Primary · 8 Weeks

CSBM2 success rate, defined as an increase from the run-in period of at least 2 weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment

Group	Value	95% CI
Vibrant Capsule	16
Sham Capsule	26

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vibrant Capsule

Serious: 1/89 (1%)

Deaths: 0/89

Sham Capsule

Serious: 1/93 (1%)

Deaths: 0/93

Serious adverse events (2 terms)

Reaction	System	Vibrant Capsule	Sham Capsule
Traumatic Fracture Of Pelvis	Musculoskeletal and connective tissue disorders	—	—
Anxiety Attack	Psychiatric disorders	—	—

Other adverse events (13 terms — click to expand)

Reaction	System	Vibrant Capsule	Sham Capsule
Sensation of vibration	Product Issues	—	—
Nausea	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Bloating	Gastrointestinal disorders	—	—
Abdominal Cramping	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Abdominal Pain	Gastrointestinal disorders	—	—
Acute Gastroenteritis	Gastrointestinal disorders	—	—
Decrease In The Frequency In Bm	Gastrointestinal disorders	—	—
Extreme Lower Abdominal Pain	Gastrointestinal disorders	—	—
Rectal Bleeding	Gastrointestinal disorders	—	—
Uncomfortable Bm	Gastrointestinal disorders	—	—
Viral Gastroenteritis	Infections and infestations	—	—

Most-reported serious reactions: Traumatic Fracture Of Pelvis, Anxiety Attack.

Data from ClinicalTrials.gov NCT03031301 adverse events section.

Sponsor's own description

The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation.

Two arms will be assessed:

* Vibrant Capsule administered 5 times per week
* Sham Capsule administered 5 times per week

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation.
   Rao SSC, Lembo A, Chey WD, Friedenberg K, et al · · 2020 · cited 22× · PMID 32449277 · DOI 10.1111/nmo.13890