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

NCT02388269 | Completed Results

• 1 other identifier: GG-007
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyspepsia; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Symptom Changes in Subjects With Functional Gastrointestinal Disorder (Functional Dyspepsia and Irritable Bowel Syndrome)

  Global Overall Symptom (GOS) scale is self-reported. Patients grade overall severity of dyspepsia symptoms over a retrospective period of time. The scale uses a 7-point Likert scale ranging from minimum 1 = no problem to maximum 7 = very severe problem. Subjects assess how their stomach problems have been over the specific time period, and indicate severity of symptoms for 10 specific upper GI symptoms (epigastric pain, epigastric discomfort, heartburn, acid regurgitation, upper abdominal bloating, excessive belching, nausea, early satiety, postprandial fullness, other epigastric symptoms). Total minimum = 10 and total maximum = 70. The Irritable Bowel Syndrome Score (IBS) measures severity of symptoms by 5 questions: abdominal pain, number days with pain in every 10 days (multiplied by 10), abdominal distension, bowel movement satisfaction, interference with general life. Each question scores from 0 (not severe) to 100 (severe). Total score: Min = 0 healthy; Max = 500 severely sick.

  Last 2 weeks in the 4 week Randomized period

Secondary Outcomes (6)

• Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)

  Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period

• Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)

  Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period

• Use of Concomitant Medication (Intake and Dose) During the Course of the Study

  Run-In (2 weeks) and Randomized (4 weeks)

• Symptom Change at 8 Weeks Compared to 4 Weeks (GOS Dyspepsia or IBS Severity Scoring System)

  Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period

• Number of Participants With Adverse Events

  Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period

Study Arms (2)

gammaCore®-G

ACTIVE COMPARATOR

The user/operator applies the gammaCore®-G device to the skin on the right side and left side of the neck. The 2 stimulations should be performed on the same side of the neck before stimulating the other side. This is also applies with the doses increase in the open label phase. The user applies conductive gel to the stimulation surfaces to maintain an uninterrupted conductive path from the stimulation surfaces to the skin. The device is capable of delivering multiple patient treatments (doses). Each dose consists of 90 seconds of stimulation; for each dose, the device is active for 120 seconds before automatically stopping stimulation.The extra 30 seconds allows .

Device: gammaCore®-G

gammaCore®-G sham

SHAM COMPARATOR

The sham device is a hand-held portable device that appears identical to the gammaCore®-G, in look, weight, visual and audible feedback, user application and control. It passes a low frequency (0.1 Hz) biphasic DC signal into the tissue, which can be felt as a tingling sensation but does not stimulate the vagus nerve or cause muscle contraction. Similar to the active device, the sensation becomes more pronounced as the amplitude is increased, until it is uncomfortable, at which point the amplitude is decreased slightly until tolerable. Like the active device, the sham device is a multi-use device capable programmed to deliver up to 150, 90-second "treatments" with a 30-second margin for set-up and operator adjustment of the "stimulation intensity".

Device: gammaCore®-G

Interventions

gammaCore®-G DEVICE

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

gammaCore®-G; gammaCore®-G sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects have to meet all of the following criteria to be eligible to enter the investigation:
• Signed Informed Consent Form
• Age \>18
• Diagnose with FD or IB Rome III criteria
• Is able to complete the diary, use the device and to follow study procedures
• Bothersome postprandial fullness
• Early satiation
• Epigastric pain
• Epigastric burning
• No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms \* Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
• Recurrent abdominal pain or discomfort\*\* at least 3 days/month in the previous 3 months associated with two or more of the following:
• Improvement with defecation
• Onset associated with a change in frequency of stool
• Onset associated with a change in form (appearance) of stool
• Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis \*\* "Discomfort" means an uncomfortable sensation not described as pain.

You may not qualify if:

• Subjects meeting any of the following criteria will not be permitted to enter the investigation:
• Any positive endoscopic findings such as abnormal biopsy findings and/or any other abnormal finding judged by the Investigator
• Any positive findings after sigmoidoscopy or colonoscopy such as diverticulosis, inflammatory bowel disease or other abnormal finding judged by the Investigator.
• Vagotomy at any location
• Has a neck lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the site gammaCore®-G treatment
• Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of transient ischemic attack (TIA) or cerebral vascular accident CVA), congestive heart failure (CHF), known severe coronary artery disease or recent (5 years) myocardial infarction
• Has an abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction
• Has uncontrolled hypertension
• Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, gastric stimulator or cochlear implant
• Has a history of carotid endarterectomy or vascular neck surgery
• Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore®-G stimulation site
• Has a recent (within 12 months) or repeated history of syncope
• Has a recent (within 12 months) or repeated history of seizures
• Has psychiatric or cognitive disorder and/or behavioural problems which in the opinion of the clinician may interfere with the study
• Is pregnant, nursing, thinking of becoming pregnant during the study period

Sponsors & Collaborators

• ElectroCore INC: lead

Study Sites (1)

Royal Free Hospital NHS Trust, Centre for Gastroenterology, 8th floor, Pond street

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Dyspepsia; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Clinical Affairs Department electroCore LLC
• Organization: electroCore LLC

clinical@electrocorellc.com

+1 973 355 6683

Study Officials

• Owen Epstein, Prof.

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 13, 2015
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 7, 2018
• Results First Posted: February 6, 2018

Record last verified: 2018-02

Locations

GB (1)