Clinical trial: A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G (NCT02388269)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? 0