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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: May 2015

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: gammaCore®-G
    • 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 .
  • Sham Comparator: gammaCore®-G sham
    • 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”.

Clinical Trial Outcome Measures

Primary Measures

  • Symptom Changes in Subjects With Functional Gastrointestinal Disorder (Functional Dyspepsia and Irritable Bowel Syndrome)
    • Time Frame: Last 2 weeks in the 4 week Randomized period
    • 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.

Secondary Measures

  • Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
    • Time Frame: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period
    • Compare Quality of Life in last 2 weeks in the randomized period with the run-in period, and compare of Quality of life in the open label period to randomization period using the Functional Digestive Disorder Quality of Life (FDDQL) questionnaire. The Functional Digestive Disorder Quality of Life (FDDQL) questionnaire is designed to measure Quality of Like (QOL) in patients with Functional Dyspepsia (FD) or Irritable Bowel Syndrome (IBS). The questionnaire is composed of 43 items (questions) investigating 8 dimensions: Daily activities, Anxiety, Diet, Sleep, Discomfort, Health, Coping and Stress. For the 43 items, patients rate the impact of their condition over the 8 dimensions from 1-5, where 1 = Not at all, 2 = A little Bit, 3 = Moderately, 4= Quite a bit, and 5 = Extremely. The mean score of the 8 dimensions is shown in the outcome measure data table.
  • Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
    • Time Frame: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period
    • Compare last 2 weeks in randomized period with the run-in period; & compare open label period to randomization period using Short-Form Dyspepsia Questionnaire (SFLDQ).The SFLDQ is a validated, self-completed questionnaire that measures frequency and severity of dyspepsia. The questionnaire comprises of 5 questions, questions 1 to 4 are about the patients dyspeptic symptoms and question 5 is about the most troublesome symptom for the patient. Questions 1 to 4 comprise of two stems concerning ‘frequency’ (how often the subject has the symptom over the last 2 months) and ‘severity’ (how often has this symptom interfered with normal activities over the last 2 months). Subjects choose from: Not at all, less than monthly, between monthly & weekly, between weekly & daily, more than daily or no response. In question 5 the subject reports which symptoms has been most troublesome for each of the study periods. Results for Question 5 of the SFLDQ are reported separately in outcome measure 7.
  • Use of Concomitant Medication (Intake and Dose) During the Course of the Study
    • Time Frame: Run-In (2 weeks) and Randomized (4 weeks)
    • Compare last 2 weeks in randomised period with the run-in period, comparison open label period to randomization period. Concomitant medications were recorded and the number of subjects taking one or more concomitant medications is compared in the active and shams groups for both Functional Dyspepsia and Irritable Bowel Syndrome cohorts during the run-in, randomized and open label periods.
  • Symptom Change at 8 Weeks Compared to 4 Weeks (GOS Dyspepsia or IBS Severity Scoring System)
    • Time Frame: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period
    • 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.
  • Number of Participants With Adverse Events
    • Time Frame: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period
    • Summary of Treatment Emergent Adverse Events. Subjects were monitored for occurrence of adverse events from the start of the run-in period to the end of the open label period..
  • Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
    • Time Frame: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period
    • Short-Form Leeds Dyspepsia Questionnaire (SFLDQ): Question 5: Most Troublesome Symptom. In question five of the SFLDQ the subject reports which of the symptoms has been most troublesome to them, this is also reported for each of the study periods. (Note: results of questions 1-4 of the SFLDQ are reported separately in outcome measure 3.)

Participating in This Clinical Trial

Inclusion Criteria

The subjects have to meet all of the following criteria to be eligible to enter the investigation:

1. Signed Informed Consent Form

2. Age >18

3. Diagnose with FD or IB Rome III criteria

4. Is able to complete the diary, use the device and to follow study procedures

5. Dyspepsia inclusion criteria, functional dyspepsia according to Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders, one or more of the following:

  • 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

6. IBS inclusion criteria, Irritable Bowel Syndrome* according to Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders

7. 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.

8. In pathophysiology research and clinical trials, a pain/discomfort frequency of at least 2 days a week during screening evaluation is recommended for subject eligibility.

Exclusion Criteria

Subjects meeting any of the following criteria will not be permitted to enter the investigation:

1. Any positive endoscopic findings such as abnormal biopsy findings and/or any other abnormal finding judged by the Investigator

2. Any positive findings after sigmoidoscopy or colonoscopy such as diverticulosis, inflammatory bowel disease or other abnormal finding judged by the Investigator.

3. Vagotomy at any location

4. Has a neck lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the site gammaCore®-G treatment

5. 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

6. 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

7. Has uncontrolled hypertension

8. 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

9. Has a history of carotid endarterectomy or vascular neck surgery

10. Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore®-G stimulation site

11. Has a recent (within 12 months) or repeated history of syncope

12. Has a recent (within 12 months) or repeated history of seizures

13. Has psychiatric or cognitive disorder and/or behavioural problems which in the opinion of the clinician may interfere with the study

14. Is pregnant, nursing, thinking of becoming pregnant during the study period

15. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial within 30 days period prior to this study

16. Is a relative of or an employee of the investigator or the clinical study site

17. Used gammaCore®-G previously

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ElectroCore INC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Owen Epstein, Prof., Principal Investigator, Royal Free Hospital NHS Foundation Trust

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