Clinical trial NCT03238534: Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS
Official title: Relief of Heartburn and Epigastric Pain Comparing Neobianacid® With Omeprazole: a Randomized, Double Blind, Double Dummy, Reference Product Controlled, Parallel Group, Non-inferiority Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: GERD
EPS
Lead sponsor: Aboca Spa Societa' Agricola
Sponsor class: INDUSTRY
Collaborators: name: Doppel Farmaceutici
name: University of Roma La Sapienza
name: BMR Genomics
First posted: 2017-08-03
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of Neobianacid® clinical efficacy to omeprazole in relief of heartburn or epigastric pain

Detailed description: Comparison of heartburn or epigastric pain severity following administration of Neobianacid® (Group B) or omeprazole (Group A) from day 0 to day 27. An ad-hoc placebo will be also administered in both treatment arms. Then, a following phase (day 28-55) will follows in which Neobianacid® will be administered (on demand) to both treatment arms.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients 18 - 70 years old (inclusive).
2. Patients presenting one or both the 2 following conditions:

   * 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.
   * 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.
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.
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 gastroenterological pathologies object of the study, according to the opinion of Investigator) are allowed, if the regimen is maintained stable during the whole study.

Exclusion Criteria:

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:

   1. anemia;
   2. chronic gastrointestinal bleeding;
   3. antibiotic use, including antifungal and antimalarial medication within 2 months preceding the start of the study;
   4. progressive unintentional weight loss;
   5. persistent or recurrent vomiting;
   6. epigastric mass;
   7. acute episode with dyspnea, diaphoresis, or tachycardia;
   8. anorexia;
   9. nausea or vomiting;
   10. 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, 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, according to concerning Summaries of Product Characteristics (SPC), e.g. for omeprazole, patients suffering from rare hereditary problems of fructose intolerance, Glucose Galactose Malabsorption (GGM) or sucrase-isomaltase deficiency.
15. Patients being treated with any drug whose pharmacokinetics can interfere with the intake of omeprazole or magaldrate (e.g., for omeprazole, the active substances known as CYP2C19 or CYP3A4 inhibitors, as clarithromycin and voriconazole, or inductors, as rifampicin and St. John's wort, Hypericum, or both) or with any drug with which omeprazole, neobianacid or magaldrate are able to interact.
16. Patient participating to any investigational drug trial within 4 weeks before screening.

Primary outcomes:
measure: Heartburn or epigastric pain severity through treatment (Day-1 to Day13)
timeFrame: Day-1 to Day13
Secondary outcomes:
measure: Heartburn or epigastric pain severity through treatment (Day-1 to Day7)
timeFrame: Day-1 to Day7
measure: Heartburn or epigastric pain severity through treatment (Day14 to Day27)
timeFrame: Day14 to Day27
measure: Assessment of of rescue medication use
timeFrame: Day-1 to Day55
measure: Tablets of Neobianacid® Vs. Neobianacid® placebo Day14 to Day27
timeFrame: Day14 to Day27
measure: Tablets of Neobianacid® Vs. Neobianacid® placebo Day28 to Day55
timeFrame: Day28 to Day55
measure: Improvement in symptomatology
timeFrame: Day-1 to Day56
measure: Improvement in quality of life
timeFrame: Day-1 to Day56
measure: Evaluation of treatment
timeFrame: Day-1 to Day56
Other outcomes:
measure: intestinal microbiota characterization
timeFrame: Day-1 and Day28
Locations:
city: Latina
country: Italy
facility: Azienda Ospedaliera Santa Maria Goretti
state: Rome
city: L'Aquila
country: Italy
facility: Ospedale Civile San Salvatore
city: Pavia
country: Italy
facility: Policlinico San Matteo Pavia Fondazione IRCCS
city: Perugia
country: Italy
facility: Azienda Ospedaliera Perugia
city: Rome
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
city: Rome
country: Italy
facility: Ospedale San Giovanni Addolorata
city: Rome
country: Italy
facility: Ospedale Sandro Pertini
city: Rome
country: Italy
facility: Ospedale Sant'Eugenio
city: Rome
country: Italy
facility: Policlinico Umberto I
city: Rome
country: Italy
facility: Policlinico Universitario A. Gemelli
city: Rome
country: Italy
facility: Policlinico Universitario Campus Biomedico di Roma
city: Salerno
country: Italy
facility: Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
Study officials:
References: