NCT02388269

A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: ElectroCore INC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study, in subjects with FGIDs, is a , randomized, sham-controlled, single-centre pilot investigation designed to compare two parallel groups, gammaCore®-G (active treatment) and a sham, (inactive) treatment. The study period will begin with a two-week run-in period, followed by a four week comparative period when the subjects will randomized (1:1) to either active treatment or sham (inactive) treatment. The comparative period will be followed by an open label four week period, where the subjects in the sham treatment group will switch in treatment assignment to receive active treatment and the active group will continue to receive an active treatment.

Conditions

• Dyspepsia
• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DEVICE	gammaCore®-G	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

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2015-03-13
• Last updated: 2018-03-07
• Results posted: 2018-02-06

Locations

1 site across 1 country: United Kingdom