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

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.

Time frame: Last 2 weeks in the 4 week Randomized period

Population: Intention To Treat population (ITT)

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.)

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.

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

Population: Intention to Treat

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..

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

Population: Safety Population

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.

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

Population: Intention To Treat population (ITT)

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.

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

Population: Intention To Treat (ITT)

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.

Time frame: Run-In (2 weeks) and Randomized (4 weeks)

Population: Intent-to-Treat