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

2015-04-08 09:38:22 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Conditions

Dyspepsia

Intervention

gammaCore®-G

Location

Royal Free Hospital NHS Trust, Centre for Gastroenterology, 8th floor, Pond street
London
United Kingdom
NW3 2QG

Status

Recruiting

Source

ElectroCore LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-04-08T09:38:22-0400

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Medical and Biotech [MESH] Definitions

Impaired digestion, especially after eating.

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