Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 . |
|
| 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". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL) | 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. |
Not provided
Inclusion Criteria:
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
Dyspepsia inclusion criteria, functional dyspepsia according to Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders, one or more of the following:
IBS inclusion criteria, Irritable Bowel Syndrome* according to Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders
Recurrent abdominal pain or discomfort** at least 3 days/month in the previous 3 months associated with two or more of the following:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Owen Epstein, Prof. | Royal Free Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Free Hospital NHS Trust, Centre for Gastroenterology, 8th floor, Pond street | London | NW3 2QG | United Kingdom |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | gammaCore®-G | Active Comparator: Active gammaCore device gammaCore active stimulation treatment |
| FG001 | gammaCore®-G Sham | Sham Comparator: sham gammaCore device gammaCore sham stimulation treatment |
| FG002 | Not Randomised | Subjects that were not randomised, i.e. screen failures |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | gammaCore®-G Functional Dyspepsia | Active Comparator: Active gammaCore device gammaCore active stimulation treatment |
| BG001 | gammaCore®-G Sham Functional Dyspepsia | Sham Comparator: sham gammaCore device gammaCore sham stimulation treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention To Treat population (ITT) | Posted | Mean | Standard Deviation | units on a scale | Last 2 weeks in the 4 week Randomized period |
Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | gammaCore®-G FD | Active Comparator: Active gammaCore device gammaCore active stimulation treatment |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MEDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Department electroCore LLC | electroCore LLC | +1 973 355 6683 | clinical@electrocorellc.com |
Not provided
| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003109 | Colonic Diseases, Functional |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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) | 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. | 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 | 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. | Run-In (2 weeks) and Randomized (4 weeks) |
| Symptom Change at 8 Weeks Compared to 4 Weeks (GOS Dyspepsia or IBS Severity Scoring System) | 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. | Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period |
| Number of Participants With Adverse Events | 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.. | 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) | 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.) | Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period |
| less than 50% stimulations |
|
| no diary data |
|
| Protocol Violation |
|
| Screen Failure |
|
| BG002 | gammaCore®-G Irritable Bowel Syndrome | Active Comparator: Active gammaCore device gammaCore active stimulation treatment |
| BG003 | gammaCore®-G Sham Irritale Bowel Syndrome | Sham Comparator: sham gammaCore device gammaCore sham stimulation treatment |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | gammaCore®-G | Active Comparator: Active gammaCore device gammaCore active stimulation treatment |
| OG001 | gammaCore®-G Sham | Sham Comparator: sham gammaCore device gammaCore sham stimulation treatment |
|
|
| Secondary | Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL) | 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. | Intention To Treat population (ITT) | Posted | Mean | Standard Deviation | units on a scale | Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period |
|
|
|
| Secondary | Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ) | 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. | Intention to Treat | Posted | Count of Participants | Participants | Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period |
|
|
|
| Secondary | Use of Concomitant Medication (Intake and Dose) During the Course of the Study | 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. | Intent-to-Treat | Posted | Count of Participants | Participants | Run-In (2 weeks) and Randomized (4 weeks) |
|
|
|
| Secondary | Symptom Change at 8 Weeks Compared to 4 Weeks (GOS Dyspepsia or IBS Severity Scoring System) | 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. | Intention To Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period |
|
|
|
| Secondary | Number of Participants With Adverse Events | 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.. | Safety Population | Posted | Count of Participants | Participants | Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period |
|
|
|
| Secondary | Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ) | 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.) | Posted | Count of Participants | Participants | Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 15 |
| 20 |
| EG001 | gammaCore®-G Sham FD | Sham Comparator: sham gammaCore device gammaCore sham stimulation treatment | 0 | 20 | 0 | 20 | 13 | 20 |
| EG002 | gammaCore®-G IBS | Active Comparator: Active gammaCore device gammaCore active stimulation treatment | 0 | 21 | 0 | 21 | 16 | 21 |
| EG003 | gammaCore®-G Sham IBS | Sham Comparator: sham gammaCore device gammaCore sham stimulation treatment | 0 | 20 | 0 | 20 | 16 | 20 |
| Ear Pain | Ear and labyrinth disorders | MEDRA | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MEDRA | Non-systematic Assessment |
|
| Blepharospasm | Eye disorders | MEDRA | Non-systematic Assessment |
|
| Conjunctivitis Allergic | Eye disorders | MEDRA | Non-systematic Assessment |
|
| Mydriasis | Eye disorders | MEDRA | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MEDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MEDRA | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MEDRA | Non-systematic Assessment |
|
| Food Poisoning | Gastrointestinal disorders | MEDRA | Non-systematic Assessment |
|
| Hypoaesthesia | Gastrointestinal disorders | MEDRA | Non-systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MEDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDRA | Non-systematic Assessment |
|
| Odynophagia | General disorders | MEDRA | Non-systematic Assessment |
|
| Paraethesia Oral | Gastrointestinal disorders | MEDRA | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MEDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDRA | Non-systematic Assessment |
|
| Chest Discomfort | General disorders | MEDRA | Non-systematic Assessment |
|
| Chest Pain | General disorders | MEDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MEDRA | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MEDRA | Non-systematic Assessment |
|
| Oedema | General disorders | MEDRA | Non-systematic Assessment |
|
| Pain | General disorders | MEDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MEDRA | Non-systematic Assessment |
|
| Tenderness | General disorders | MEDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MEDRA | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MEDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MEDRA | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MEDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MEDRA | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | MEDRA | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MEDRA | Non-systematic Assessment |
|
| Ligament Injury | Injury, poisoning and procedural complications | MEDRA | Non-systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MEDRA | Non-systematic Assessment |
|
| Stress Fracture | Injury, poisoning and procedural complications | MEDRA | Non-systematic Assessment |
|
| Tendon injury | Injury, poisoning and procedural complications | MEDRA | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MEDRA | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MEDRA | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MEDRA | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MEDRA | Non-systematic Assessment |
|
| MuscleTwitching | Musculoskeletal and connective tissue disorders | MEDRA | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MEDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MEDRA | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MEDRA | Non-systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MEDRA | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDRA | Non-systematic Assessment |
|
| Pain in Jaw | Musculoskeletal and connective tissue disorders | MEDRA | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MEDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MEDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MEDRA | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MEDRA | Non-systematic Assessment |
|
| Hypokinesia | Nervous system disorders | MEDRA | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MEDRA | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MEDRA | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MEDRA | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MEDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MEDRA | Non-systematic Assessment |
|
| Panic Attack | Product Issues | MEDRA | Non-systematic Assessment |
|
| Renal Colic | Renal and urinary disorders | MEDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MEDRA | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MEDRA | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDRA | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDRA | Non-systematic Assessment |
|
| Respiratory Tract Ulceration | Respiratory, thoracic and mediastinal disorders | MEDRA | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MEDRA | Non-systematic Assessment |
|
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MEDRA | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MEDRA | Non-systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MEDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MEDRA | Non-systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | MEDRA | Non-systematic Assessment |
|
| Skin Lesion | Skin and subcutaneous tissue disorders | MEDRA | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MEDRA | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MEDRA | Non-systematic Assessment |
|
Not provided
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| Daily Activities - Randomized Period |
|
| Daily Activities - Open label |
|
| Anxiety - Run-in |
|
| Anxiety - Randomized |
|
| Anxiety - Open-label |
|
| Diet - Run-in |
|
| Diet - Randomized |
|
| Diet - Open-label |
|
| Sleep - Run-in |
|
| Sleep - Randomized |
|
| Sleep - Open label |
|
| Discomfort - Run-in |
|
| Discomfort - Randomized |
|
| Discomfort - Open label |
|
| Health - Run-in |
|
| Health - Randomized |
|
| Health - Open label |
|
| Coping - Run-in |
|
| Coping - Randomized |
|
| Coping - Open label |
|
| Stress - Run-in |
|
| Stress - Randomized |
|
| Stress - Open label |
|
| INDIGESTION:Run-in - Less than monthly |
|
| INDIGESTION:Run-in - Between weekly & monthly |
|
| INDIGESTION:Run-in -Between weekly & daily |
|
| INDIGESTION:Run-in - More than daily |
|
| INDIGESTION:Run-in - No response |
|
| INDIGESTION:Randomized- Not at all |
|
| INDIGESTION:Randomized- Less than monthly |
|
| INDIGESTION:Randomized- Between weekly & monthly |
|
| INDIGESTION:Randomized- Between weekly & daily |
|
| INDIGESTION:Randomized- More than daily |
|
| INDIGESTION:Randomized- No response |
|
| INDIGESTION:Open-label- Not at all |
|
| INDIGESTION:Open-label- Less than monthly |
|
| INDIGESTION:Open-label- Between monthly & weekly |
|
| INDIGESTION:Open-label- Between weekly an daily |
|
| INDIGESTION:Open-label- More than daily |
|
| INDIGESTION:Open-label- No response |
|
| HEARTBURN:Run-in- Not at all |
|
| HEARTBURN:Run-in- Less than monthly |
|
| HEARTBURN:Run-in- Between monthly & weekly |
|
| HEARTBURN:Run-in- Between weekly & daily |
|
| HEARTBURN:Run-in- More than daily |
|
| HEARTBURN:Run-in- No response |
|
| HEARTBURN:Randomised- Not at all |
|
| HEARTBURN:Randomised- Less than monthly |
|
| HEARTBURN:Randomised- Between monthly and weekly |
|
| HEARTBURN:Randomised- Between weekly and daily |
|
| HEARTBURN:Randomised- More than daily |
|
| HEARTBURN:Randomised- No response |
|
| HEARTBURN:Open-label- Not at all |
|
| HEARTBURN:Open-label- Less than monthly |
|
| HEARTBURN:Open-label- Between monthly & weekly |
|
| HEARTBURN:Open-label- Between weekly and daily |
|
| HEARTBURN:Open-label- More than daily |
|
| HEARTBURN:Open-label- No reposnse |
|
| REGURGITATION:Run-in- Not at all |
|
| REGURGITATION:Run-in- Less than monthly |
|
| REGURGITATION:Run-in- Between monthly and weekly |
|
| REGURGITATION:Run-in- Between weekly & daily |
|
| REGURGITATION:Run-in- More than daily |
|
| REGURGITATION:Run-in- No response |
|
| REGURGITATION:Randomized- Not at all |
|
| REGURGITATION:Randomized- Less than monthly |
|
| REGURGITATION:Randomized- Between monthly & weekly |
|
| REGURGITATION:Randomized- Between weekly & daily |
|
| REGURGITATION:Randomized- More than daily |
|
| REGURGITATION:Randomized- No response |
|
| REGURGITATION:Open-label- Not at all |
|
| REGURGITATION:Open-label- Less than monthly |
|
| REGURGITATION:Open-label- Between monthly & weekly |
|
| REGURGITATION:Open-label- Between weekly & daily |
|
| REGURGITATION:Open-label- More than daily |
|
| REGURGITATION:Open-label- No response |
|
| NAUSEA:Run-in- Not at all |
|
| NAUSEA:Run-in- Less than monthly |
|
| NAUSEA:Run-in- Between monthly & weekly |
|
| NAUSEA:Run-in- Bewteen weekly & daily |
|
| NAUSEA:Run-in- More than daily |
|
| NAUSEA:Run-in- No response |
|
| NAUSEA:Randomized- Not at all |
|
| NAUSEA:Randomized- Less than monthly |
|
| NAUSEA:Randomized- etween monthly & weekly |
|
| NAUSEA:Randomized- Between weekly & daily |
|
| NAUSEA:Randomized- More than daily |
|
| NAUSEA:Randomized- No response |
|
| Nausea: Open-label- Not at all |
|
| Nausea: Open-label- Less than monthly |
|
| Nausea: Open-label- Between monthly & weekly |
|
| Nausea: Open-label- Between weekly & daily |
|
| Nausea: Open-label- More than daily |
|
| Nausea: Open-label- No response |
|
| Subjects taking multiple medications in randomised |
|
| Irritable Bowel Syndrome |
|
|
| At least one related event |
|
| At least one adverse device effect |
|
| At least one severe event |
|
| At least one serious event |
|
| At least one event leading to discontinuation |
|
| Run-in - Regurgitation |
|
| Run-in - Nausea |
|
| Run-in - None of these have troubled me |
|
| Run-in Missing |
|
| Randomized - Indigestion |
|
| Randomized - Heartburn |
|
| Randomized - Regurgitation |
|
| Randomized - Nausea |
|
| Randomized - None of these have troubled me |
|
| Randomized - Missing |
|
| Open-Label - Indigestion |
|
| Open-Label - Heartburn |
|
| Open-Label - Regurgitation |
|
| Open-Label - Nausea |
|
| Open-Label - None of these have troubled me |
|
| Open-Label - Missing |
|