GG-007
Research type
Research Study
Full title
A randomized, single centre, double-blind, parallel, sham-controlled pilot study of the gammaCore®-G, a non-invasive neurostimulator device for the daily treatment of symptoms caused by Functional Gastrointestinal Disorder (Functional dyspepsia and Irritable bowel syndrome)
IRAS ID
150515
Contact name
Owen Epstein
Contact email
Sponsor organisation
electroCore LLC
Research summary
This is a study of the gammaCore®-G medical device, a non-invasive neurostimulator device to compare the usefulness of the gammaCore®-G device for symptom decrease in subjects with functional gastric disorder by comparing the outcomes of treatment between the active gammaCore®-G and inactive sham device stimulation during the randomized phase.
In the run-in (baseline) period the subjects will continue using their existing treatment prescribed or over the counter medication.
After the run-in period the subjects will be randomized to self-treatment with either an active or sham device for four weeks.
During the final four weeks the study subjects randomized to the sham treatment group will receive an active device. The subjects will be instructed to treat three times a day with 6-7 hours apart with the gammaCore®-G device. The subject will still record any medication taken to relieve gastrointestinal symptoms.
The primary objective is to compare the pain free rates during the two week randomized phase between the two parallel groups.
The comparative period will be followed by 2 weeks of treatment with
GammaCore for both groups. There are four visits during the study over the time of 6 weeks. During the study, patient
will undergo different evalutions, like physical examination, vitals and ECGs. Patient will alos complete questionnaire.
There is only one site in UK (Royal Free Hopital, London) for this study. There are two sites in Ireland.REC name
London - Stanmore Research Ethics Committee
REC reference
14/LO/0374
Date of REC Opinion
8 Apr 2014
REC opinion
Further Information Favourable Opinion