GERD (Gastroesophageal Reflux Disease) and/or EPS (Epigastric Pain Syndrome) MedDRA version: 20.1 Level: LLT Classification code 10015015 Term: Epigastric burning System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10066998 Term: Gastroesophageal burning System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10066990 Term: Gastrooesophageal burning System Organ Class: 100000004856
Conditions
Interventions
Trade Name: OMEPRAZOLO DOC GENERICI - 20 MG CAPSULE RIGIDE GASTRORESISTENTI 14 CAPSULE IN BLISTER AL/AL
Product Name: Omeprazolo
Product Code: NA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN
Sponsors
ABOCA S.P.A. SOCIETà AGRICOLA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who will meet all the following criteria will be eligible to enter the study. 1. Male and female patients 18 - 70 years old (inclusive). 2. Patients presenting one or both the 2 following conditions: o Patients presenting heartburn who have been already diagnosed with uncomplicated gastroesophageal reflux disease (GERD) or whose symptoms are consistent with a clinical diagnosis of uncomplicated GERD. The typical reflux syndrome is defined by the presence of characteristic symptoms i.e. troublesome heartburn alone or associated with regurgitation, according to the following definitions [Montreal Global definition and classification of gastroesophageal reflux disease]: - heartburn is defined as a burning sensation in the retrosternal area (behind the breastbone), i.e. a burning feeling rising from the stomach or lower chest towards the neck; - regurgitation is defined as the perception of flow of refluxed gastric content into the mouth or hypopharynx, i.e. as the spontaneous return of gastric or esophageal contents into the pharynx or as the presence of an acid taste in the mouth or an unpleasant movement of material upwards from the stomach. o Patients who have been already diagnosed with uncomplicated Epigastric Pain Syndrome (EPS) or whose symptoms are consistent with a clinical diagnosis of uncomplicated EPS according to Rome III criteria. B1b. Epigastric Pain Syndrome Diagnostic criteria* must include all of the following: - Pain or burning localized to the epigastrium of at least moderate severity, at least once per week. - The pain is intermittent. - Not generalized or localized to other abdominal or chest regions. - Not relieved by defecation or passage of flatus. - Not fulfilling criteria for gallbladder and sphincter of Oddi disorders. *Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis Supportive criteria - The pain may be of a burning quality. - The pain is commonly induced or relieved by ingestion of a meal, but may occur while fasting. - Postprandial distress syndrome may coexist. 3. A gastroscopy is to be performed if not already performed during the previous 3 years and the symptomatology is unchanged. 4. Patients having a VAS score = 30mm and = 70mm (VAS related to heartburn/ epigastric pain) for at least 6 out of 14 days preceding the screening visit. 5. Postmenopausal women i.e. women who have not experienced a menstrual bleed for a minimum of 12 months or women who have undergone surgical sterilization (tubal closure or ovaries removal). Otherwise, necessity for women of childbearing potential to follow a reliable contraceptive treatment. Contraceptive treatments deemed as reliable for the study purposes are the following: - hormonal contraceptives (pill, patch, vaginal ring), intrauterine devices (IUD), subcutaneous implants; - barrier systems as condoms or diaphragm and methods based on the recognition of fertility from an hormonal point of view. 6. Ability of the patients (in the Investigator’s opinion) to comprehend the full nature and purpose of the study including possible risks and side effects. 7. Patients who agree not to alter their diet in any way for the duration of the trial and to maintain it at steady state. 8. Patients who agree not to make any major lifestyle changes during the trial. 9. Consent to the study and willing to comply with all its procedures. 10. Chronic therapies (if not related to the gastroentero
Exclusion criteria
Exclusion criteria: Patients with any one of the following conditions will be ineligible to enter the study. 1. Patients with heartburn/epigastric pain who have not previously responded to antacid or PPI. 2. Patients having a VAS score > 70mm (VAS related to heartburn/ epigastric pain) for at least 6 out of 14 days preceding the screening visit. 3. Patient presenting one of the following condition: a. anemia; b. chronic gastrointestinal bleeding; c. antibiotic use; d. progressive unintentional weight loss; e. persistent or recurrent vomiting; f. epigastric mass; g. acute episode with dyspnea, diaphoresis, or tachycardia; h. anorexia; i. nausea or vomiting; j. dysphagia or odynophagia. 4. Patients under triple therapy or eradication therapy against Helicobacter pylori. 5. Patients using any drugs that could affect symptoms, such as NSAIDS, antacids, anti- secretory agents including proton pump inhibitors (other than the study products) and histamine H2-receptor antagonists or prokinetic or antiulcer agents, gastric mucosal protectants (other than the study products), anticholinergics and / or cholinergic agents. Moreover, the patients will be asked to avoid any drugs of the above mentioned since the beginning of the study (since pre-screening visit) until the end of the study. 6. Patients with the presence of the following conditions: erosive GERD, Barrett’s oesophagus or oesophageal stricture, active or healing gastroduodenal ulcer (except scars) or any other GI disease, which is not mentioned in the inclusion criteria; history of gastric, duodenal or esophageal surgery; malignant disease of any kind; gallstone. Any chronic disease that may affect the gastrointestinal upper tract. 7. Patients with clinically significant liver disease (AST/SGOT, ALT/SGPT >2 upper limits of normal). 8. Patients with clinically significant renal disease (serum creatinine >1.5 mg/dl). 9. Patient having any other conditions or disease that the Investigator will consider non-appropriate to the study (any severe disease of another major body system other than GI tract). 10. Patients with porphyria, hypophosphatemia, cachexia. 11. Pregnant or nursing women or women planning to become pregnant during the study. 12. Patients with a history of alcohol or drug abuse. 13. Known hypersensitivity or intolerance to any components of the study products or rescue medication. 14. Subjects presenting contraindications to the study products or rescue medication. 15. Patient participating to any investigational drug trial within 4 weeks before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Comparison of heartburn or epigastric pain severity by means of a 100mm VAS scale (from “no symptoms” to “overwhelming symptoms”); from Baseline to Day 13, between groups. Baseline is defined as Day -1 (the evaluations to be considered for the Baseline have to be obtained at Day -1, i.e. at V0). ;Timepoint(s) of evaluation of this end point: daily, from Baseline to Day 13.;Secondary Objective: •Comparison of heartburn or epigastric pain severity by means of a 100mm VAS scale; •Assessment of use (starting date and quantity) of rescue medication (antacid); •Assessment of number of tablets of Neobianacid® on demand in comparison to Neobianacid® placebo on demand; •Improvement in symptomatology, by means of Gastrointestinal Symptom Rating Scale Questionnaire – GSRS; •Improvement in quality of life, by means of Gastrointestinal Quality of Life Index - GIQLI questionnaire; •Evaluation of treatment by means of Overall Treatment Evaluation – OTE; ;Main Objective: To compare Neobianacid® clinical efficacy with omeprazole, 20 mg once a day (q.d.), in relief of heartburn or epigastric pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Comparison of heartburn or epigastric pain severity by means of a 100mm VAS scale (from “no symptoms” to “overwhelming symptoms”); 2 - Assessment of heartburn or epigastric pain severity by means of a 100mm VAS scale (from “no symptoms” to “overwhelming symptoms”); 3 - Assessment of use (starting date and quantity) of rescue medication (antacid); 4 - Assessment of number of tablets of Neobianacid® on demand in comparison to Neobianacid® placebo on demand; 5 - Assessment of number of tablets of Neobianacid® on demand; 6 - Improvement in symptomatology, by means of Gastrointestinal Symptom Rating Scale Questionnaire – GSRS; 7 - Improvement in quality of life, by means of Gastrointestinal Quality of Life Index - GIQLI questionnaire; 8 - Evaluation of treatment by means of Overall Treatment Evaluation – OTE;;Timepoint(s) of evaluation of this end point: 1 - from Baseline to Day 1, Day 3 and Day 7, between groups. 2 - from Day 14 to Day 27, between groups. 3 - from Baseline to Day 13, from Day 14 to Day 27 and from Day 28 to Day 55, between groups. 4 - from Day 14 to Day 27, between groups. 5 - from Day 28 to Day 55, between groups. 6 - Day 14, Day 28 and Day 56 versus Baseline, between groups. 7 - Day 14, Day 28 and Day 56 versus Baseline, between groups. 8 - Day 14, 28 and 56, between groups. | — |
Countries
Italy
Contacts
Public ContactDr.ssa Anna Maidecchi
Aboca S.p.A. Società Agricola
Outcome results
None listed