Clinical trial NCT02388269: A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspepsia
Irritable Bowel Syndrome
Lead sponsor: ElectroCore INC
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptom Changes in Subjects With Functional Gastrointestinal Disorder (Functional Dyspepsia and Irritable Bowel Syndrome)
timeFrame: Last 2 weeks in the 4 week Randomized period
Secondary outcomes:
measure: Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
timeFrame: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period
measure: Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
timeFrame: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period
measure: Use of Concomitant Medication (Intake and Dose) During the Course of the Study
timeFrame: Run-In (2 weeks) and Randomized (4 weeks)
measure: Symptom Change at 8 Weeks Compared to 4 Weeks (GOS Dyspepsia or IBS Severity Scoring System)
timeFrame: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period
measure: Number of Participants With Adverse Events
timeFrame: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period
measure: Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
timeFrame: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital NHS Trust, Centre for Gastroenterology, 8th floor, Pond street
Study officials:
affiliation: Royal Free Hospital NHS Foundation Trust
name: Owen Epstein, Prof.
role: PRINCIPAL_INVESTIGATOR
References: