At a glance

ClinicalIndex Comparison Record

N/ACompleted· 91 enrolled

Drug / intervention

gammaCore®-Gdevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02388269

NCT02388269N/ACompleted

Compare CT.gov

A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study of the gammaCore®-G, a Non-invasive Vagus Nerve Stimulator Device for Treatment of Symptoms Caused by Functional Dyspepsia or Irritable Bowel Syndrome

ElectroCore INC·interventional·Posted Mar 13, 2015·Updated Mar 7, 2018

In Brief

A clinical study evaluating gammaCore®-G for Dyspepsia and Irritable Bowel Syndrome. Completed, enrolled 91 participants across 1 site.

Detailed Summary

A randomized, sham-controlled, single-centre pilot investigation designed to compare two parallel groups, gammaCore®-G (active treatment) and a sham, (inactive) treatment in subjects with FGIDs.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDyspepsia, Irritable Bowel Syndrome

CountriesUnited Kingdom

Collaborators--

Timeline

N/ACompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartJun 2014

First PostedMar 2015

Primary CompletionMay 2015

Study CompletionJun 2015

TodayJul 2026

First PostedMar 13, 2015

Enrollment StartJun 1, 2014

Primary CompletionMay 1, 2015

Study CompletionJun 1, 2015

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 11.3 years ago

Interventions

gammaCore®-Gdevice

The gammaCore®-G device is a reusable, hand-held, portable device consisting of two 3.0 VDC batteries (not replaceable or user serviceable), signal generating and amplifying electronics, and two buttons for operator control of the signal amplitude. The device provides visible (light display) and audible feedback on device and stimulation status