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GERDPhase 4NCT03238534

Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS

A Phase 4 study testing Neobianacid® and Omeprazole 20mg in people with GERD and EPS, run by Aboca Spa Societa' Agricola at 12 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Comparison of Neobianacid® clinical efficacy to omeprazole in relief of heartburn or epigastric pain Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
GERD, EPS
What is being tested?
Neobianacid® and Omeprazole 20mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
275 participants
Where
12 sitesItaly
Study dates
12 Sep 2017to 3 Sep 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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;
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  • 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.
  • 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.
  • Patients with clinically significant liver disease (AST/SGOT, ALT/SGPT >2 upper limits of normal).
  • Patients with clinically significant renal disease (serum creatinine >1.5 mg/dl).
  • 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).
  • Patients with porphyria, hypophosphatemia, cachexia.
  • Pregnant or nursing women or women planning to become pregnant during the study.
  • Patients with a history of alcohol or drug abuse.
  • Known hypersensitivity or intolerance to any components of the study products or rescue medication.
  • 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.
  • 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.
  • Patient participating to any investigational drug trial within 4 weeks before screening.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Italy12 sites

  • Ospedale Civile San Salvatore

    L’Aquila

  • Azienda Ospedaliera Santa Maria Goretti

    Latina, Rome

  • Policlinico San Matteo Pavia Fondazione IRCCS

    Pavia, 27100

  • Azienda Ospedaliera Perugia

    Perugia

  • Azienda Ospedaliera Sant'Andrea

    Rome

  • Ospedale San Giovanni Addolorata

    Rome

  • Ospedale Sandro Pertini

    Rome

  • Ospedale Sant'Eugenio

    Rome

  • Policlinico Umberto I

    Rome

  • Policlinico Universitario A. Gemelli

    Rome

  • Policlinico Universitario Campus Biomedico di Roma

    Rome

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

    Salerno, 84131

Other trials in Italy

About this study

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

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

Read the 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.

Conditions
GERD, EPS
Being tested
Neobianacid®, Omeprazole 20mg, Neobianacid® placebo, Omeprazole placebo
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neobianacid®Device

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

  • Omeprazole 20mgDrug

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

  • Neobianacid® placeboOther

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

  • Omeprazole placeboOther

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

Study groups in NCT03238534
Study groupRoleWhat they receive
Omeprazole 20mgActive comparatorPatients 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
Receives: Drug: Omeprazole 20mg; Other: Neobianacid® placebo
Neobianacid®ExperimentalPatients 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
Receives: Device: Neobianacid®; Other: Omeprazole placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day-1 to Day13

Secondary outcomes (8)

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

    Comparison of heartburn or epigastric pain severity by means of a 100mm VAS scale (from "no symptoms" to "overwhelming symptoms") from Baseline to Day 1, Day 3 and Day 7, between groups

    Measured: Day-1 to Day7

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

    Assessment of heartburn or epigastric pain severity by means of a 100mm VAS scale (from "no symptoms" to "overwhelming symptoms"); from Day 14 to Day 27 between groups.

    Measured: Day14 to Day27

  3. Assessment of of rescue medication use

    Assessment of use (starting date and quantity) of rescue medication (antacid); from Baseline to Day 13, from Day 14 to Day 27 and from Day 28 to Day 55, between groups.

    Measured: Day-1 to Day55

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

    Assessment of number of tablets of Neobianacid® on demand in comparison to Neobianacid® placebo on demand; from Day 14 to Day 27, between groups.

    Measured: Day14 to Day27

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

    Assessment of number of tablets of Neobianacid® on demand; from Day 28 to Day 55, between groups.

    Measured: Day28 to Day55

  6. Improvement in symptomatology

    Improvement in symptomatology, by means of Gastrointestinal Symptom Rating Scale Questionnaire - GSRS; Day 14, Day 28 and Day 56 versus Baseline, between groups.

    Measured: Day-1 to Day56

  7. Improvement in quality of life

    Improvement in quality of life, by means of Gastrointestinal Quality of Life Index - GIQLI questionnaire; Day 14, Day 28 and Day 56 versus Baseline, between groups.

    Measured: Day-1 to Day56

  8. Evaluation of treatment

    Evaluation of treatment by means of Overall Treatment Evaluation - OTE; Day 14, 28 and 56, between groups.

    Measured: Day-1 to Day56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2017
  2. Study start12 Sep 2017
  3. Primary completion3 Sep 2021
  4. Study completion3 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03238534
Sponsor's protocol ID
ABO-NB-15
Status last verified
Dec 2021
First submitted
1 Aug 2017
Last updated
21 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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, Iovino P, Badiali D. Poliprotect in the PPI Deprescription Phase of Endoscopy-Negative Heartburn and Epigastric Pain Syndrome Patients: An RCT Post Hoc Analysis. Neurogastroenterol Motil. 2026 Jun;38(6):e70370. doi: 10.1111/nmo.70370.

    PubMed 42226497

  • 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.

    PubMed 37307528

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Neobianacid® and Omeprazole 20mg in people with GERD and EPS, run by Aboca Spa Societa' Agricola at 12 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heartburn or epigastric pain severity through treatment (Day-1 to Day13) (time frame: Day-1 to Day13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03238534, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.

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