Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS

NCT03238534 | Completed Phase 4

• 1 other identifier: ABO-NB-15
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

GERD; EPS

Outcome Measures

Primary Outcomes (1)

• Heartburn or epigastric pain severity through treatment (Day-1 to Day13)

  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

  Day-1 to Day13

Secondary Outcomes (8)

• Heartburn or epigastric pain severity through treatment (Day-1 to Day7)

  Day-1 to Day7

• Heartburn or epigastric pain severity through treatment (Day14 to Day27)

  Day14 to Day27

• Assessment of of rescue medication use

  Day-1 to Day55

• Tablets of Neobianacid® Vs. Neobianacid® placebo Day14 to Day27

  Day14 to Day27

• Tablets of Neobianacid® Vs. Neobianacid® placebo Day28 to Day55

  Day28 to Day55

Other Outcomes (1)

• intestinal microbiota characterization

  Day-1 and Day28

Study Arms (2)

Omeprazole 20mg

ACTIVE COMPARATOR

Patients will be provided with enough amount of 20 mg omeprazole \[30' before meal\] and Neobianacid® placebo \[30' after meal\] (both per os) to complete the first phase of the treatment (day 1-27). Then, at day 28, the patients will be provided with Neobianacid® that can be administered on demand until the study end (day 56). Malgradate will be also provided as rescue medication. Treatment regimen: Day 0-13 Breakfast: Omeprazole + Neobianacid® placebo; Lunch: Neobianacid® placebo; Midafternoon: Neobianacid® placebo; Dinner: Neobianacid® placebo; Before going to bed: Neobianacid® placebo. Day14-27 Breakfast: Omeprazole+ Neobianacid® placebo on demand Lunch: Neobianacid® placebo on demand Dinner: Neobianacid® placebo on demand Any other time: Neobianacid® placebo on demand, if needed Day28-55 Breakfast: Neobianacid® on demand Lunch: Neobianacid® on demand Dinner: Neobianacid® on demand Any other time: Neobianacid® on demand, if needed

Drug: Omeprazole 20mg; Other: Neobianacid® placebo

Neobianacid®

EXPERIMENTAL

Patients will be provided with enough amount of Omeprazole placebo \[30' before meal\] and Neobianacid® \[30' after meal\] (both per os) to complete the first phase of the treatment (day 1-27). Then, at day 28, the patients will be provided with Neobianacid® that can be administered on demand until the study end (day 56). Malgradate will be also provided as rescue medication. Treatment regimen: Day 0-13 Breakfast: Omeprazole placebo + Neobianacid® Lunch: Neobianacid® Midafternoon: Neobianacid® Dinner: Neobianacid® Before going to bed: Neobianacid® Day14-27 Breakfast: Omeprazole placebo + Neobianacid® on demand Lunch: Neobianacid® on demand Dinner: Neobianacid® on demand Any other time: Neobianacid® on demand, if needed Day28-55 Breakfast: Neobianacid® on demand Lunch: Neobianacid® on demand Dinner: Neobianacid® on demand Any other time: Neobianacid® on demand, if needed

Device: Neobianacid®; Other: Omeprazole placebo

Interventions

Neobianacid® DEVICE

Oral administrations of Neobianacid® (30' after meals and on demand)

Neobianacid®

Omeprazole 20mg DRUG

Daily administration Omeprazole 20mg (per os, 30' before breakfast).

Omeprazole 20mg

Neobianacid® placebo OTHER

Oral administrations of Neobianacid® placebo (30' after meals and on demand)

Omeprazole 20mg

Omeprazole placebo OTHER

Daily administration Omeprazole placebo (per os, 30' before breakfast).

Neobianacid®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 18 - 70 years old (inclusive).
• 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.
• A gastroscopy is to be performed if not already performed during the previous 3 years and the symptomatology is unchanged.
• 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.
• 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.
• 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.
• Patients who agree not to alter their diet in any way for the duration of the trial and to maintain it at steady state.
• Patients who agree not to make any major lifestyle changes during the trial.
• Consent to the study and willing to comply with all its procedures.
• 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.

You may not qualify if:

• Patients with heartburn/epigastric pain who have not previously responded to antacid or PPI.
• Patients having a VAS score \> 70mm (VAS related to heartburn/ epigastric pain) for at least 6 out of 14 days preceding the screening visit.
• Patient presenting one of the following condition:
• anemia;
• chronic gastrointestinal bleeding;
• antibiotic use, including antifungal and antimalarial medication within 2 months preceding the start of the study;
• progressive unintentional weight loss;
• persistent or recurrent vomiting;
• epigastric mass;
• acute episode with dyspnea, diaphoresis, or tachycardia;
• anorexia;
• nausea or vomiting;
• dysphagia or odynophagia.
• Patients under triple therapy or eradication therapy against Helicobacter pylori.
• 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.

Sponsors & Collaborators

• Aboca Spa Societa' Agricola: lead
• Doppel Farmaceutici: collaborator
• University of Roma La Sapienza: collaborator
• BMR Genomics: collaborator

Study Sites (12)

Azienda Ospedaliera Santa Maria Goretti

Latina, Rome, Italy

Location

Ospedale Civile San Salvatore

L’Aquila, Italy

Location

Policlinico San Matteo Pavia Fondazione IRCCS

Pavia, 27100, Italy

Location

Azienda Ospedaliera Perugia

Perugia, Italy

Location

Azienda Ospedaliera Sant'Andrea

Rome, Italy

Location

Ospedale San Giovanni Addolorata

Rome, Italy

Location

Ospedale Sandro Pertini

Rome, Italy

Location

Ospedale Sant'Eugenio

Rome, Italy

Location

Policlinico Umberto I

Rome, Italy

Location

Policlinico Universitario A. Gemelli

Rome, Italy

Location

Policlinico Universitario Campus Biomedico di Roma

Rome, Italy

Location

Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona

Salerno, 84131, Italy

Location

Related Publications (1)

• Corazziari ES, Gasbarrini A, D'Alba L, D'Ovidio V, Riggio O, Passaretti S, Annibale B, Cicala M, Repici A, Bassotti G, Ciacci C, Di Sabatino A, Neri M, Bragazzi MC, Ribichini E, Radocchia G, Iovino P, Marazzato M, Schippa S, Badiali D. Poliprotect vs Omeprazole in the Relief of Heartburn, Epigastric Pain, and Burning in Patients Without Erosive Esophagitis and Gastroduodenal Lesions: A Randomized, Controlled Trial. Am J Gastroenterol. 2023 Nov 1;118(11):2014-2024. doi: 10.14309/ajg.0000000000002360. Epub 2023 Jun 13.

  PMID: 37307528 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind (patient+investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: September 12, 2017
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: November 21, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (12)