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Efficacy and Safety of Vibrant Capsule vs. Vibrant Placebo for the Treatment of Chronic Idiopathic Constipation (CIC)

NCT04458675 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-06-14

Study results available
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Summary

The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for the treatment of subjects with functional Constipation.

Conditions

  • Chronic Idiopathic Constipation

Interventions

DEVICE

Vibrant capsule

The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility

DRUG

Placebo

A biodegradable capsule, which visually similar to the Vibrant active capsule

Sponsors & Collaborators

  • Vibrant Ltd.

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2019-01-07
Completion
2019-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04458675 on ClinicalTrials.gov