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Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS

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ClinicalTrials.gov Identifier: NCT03238534
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : May 15, 2018
Sponsor:
Collaborators:
Sprim Advanced Life Sciences
Doppel Farmaceutici
University of Roma La Sapienza
BMR Genomics
Clinpharma
Information provided by (Responsible Party):
Aboca Spa Societa' Agricola

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

Condition or disease Intervention/treatment Phase
GERD EPS Device: Neobianacid® Drug: Omeprazole 20mg Other: Neobianacid® placebo Other: Omeprazole placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double Blind (patient+investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn

Arm Intervention/treatment
Active Comparator: Omeprazole 20mg

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 (both 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

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

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

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

Experimental: Neobianacid®

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

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




Primary Outcome Measures :
  1. Heartburn or epigastric pain severity through treatment (Day-1 to Day13) [ Time Frame: 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


Secondary Outcome Measures :
  1. Heartburn or epigastric pain severity through treatment (Day-1 to Day7) [ Time Frame: 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

  2. Heartburn or epigastric pain severity through treatment (Day14 to Day27) [ Time Frame: 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.

  3. Assessment of of rescue medication use [ Time Frame: Day-1 to Day55 ]
    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.

  4. Tablets of Neobianacid® Vs. Neobianacid® placebo Day14 to Day27 [ Time Frame: 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.

  5. Tablets of Neobianacid® Vs. Neobianacid® placebo Day28 to Day55 [ Time Frame: Day28 to Day55 ]
    Assessment of number of tablets of Neobianacid® on demand; from Day 28 to Day 55, between groups.

  6. Improvement in symptomatology [ Time Frame: Day-1 to Day56 ]
    Improvement in symptomatology, by means of Gastrointestinal Symptom Rating Scale Questionnaire - GSRS; Day 14, Day 28 and Day 56 versus Baseline, between groups.

  7. Improvement in quality of life [ Time Frame: Day-1 to Day56 ]
    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.

  8. Evaluation of treatment [ Time Frame: Day-1 to Day56 ]
    Evaluation of treatment by means of Overall Treatment Evaluation - OTE; Day 14, 28 and 56, between groups.


Other Outcome Measures:
  1. intestinal microbiota characterization [ Time Frame: Day-1 and Day28 ]
    Characterization of the whole intestinal microbiota carried out by means of the analysis of faecal samples; Baseline and Day 28.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238534


Contacts
Contact: Niccolò Ravenni, Dr. +39 0575 746 ext 711 nravenni@aboca.it

Locations
Italy
Azienda Ospedaliera Santa Maria Goretti Recruiting
Latina, Rome, Italy
Contact: Oliviero Riggio, Prof.         
Sub-Investigator: Lorenzo Ridola, Dr.         
Ospedale Civile San Salvatore Recruiting
L'Aquila, Italy
Contact: Giuseppe Frieri, Prof.         
Sub-Investigator: Filippo Vernia, Dr.         
Azienda Ospedaliera Perugia Recruiting
Perugia, Italy
Contact: Gabrio Bassotti, Prof.         
Sub-Investigator: Michele Cacioni, Dr.         
Azienda Ospedaliera Sant'Andrea Recruiting
Rome, Italy
Contact: Bruno Annibale, Prof.         
Sub-Investigator: Anna Rinzivillo, Dr.         
Ospedale San Giovanni Addolorata Recruiting
Rome, Italy
Contact: Lucia D'Alba, Dr.         
Sub-Investigator: Maria Giovanna Graziani, Dr.         
Ospedale Sandro Pertini Recruiting
Rome, Italy
Contact: Giuseppe Occhigrossi, Prof.         
Sub-Investigator: Pierluigi Fracasso, Dr.         
Sub-Investigator: Andrea Cocco, Dr.         
Ospedale Sant'Eugenio Recruiting
Rome, Italy
Contact: Valeria D'Ovidio, Dr.         
Sub-Investigator: Lucia Miglioresi, Dr.         
Policlinico Umberto I Recruiting
Rome, Italy
Contact: Danilo Badiali, Prof.         
Sub-Investigator: Emanuela Ribichini, Dr.         
Policlinico Universitario A. Gemelli Recruiting
Rome, Italy
Contact: Antonio Gasbarrini, Prof.         
Sub-Investigator: Francesca D'Aversa, Dr.         
Policlinico Universitario Campus Biomedico di Roma Recruiting
Rome, Italy
Contact: Michele Cicala, Prof.         
Sub-Investigator: Mentore Ribolsi, Dr.         
Sub-Investigator: Dario Biasutto, Dr.         
Sponsors and Collaborators
Aboca Spa Societa' Agricola
Sprim Advanced Life Sciences
Doppel Farmaceutici
University of Roma La Sapienza
BMR Genomics
Clinpharma

Responsible Party: Aboca Spa Societa' Agricola
ClinicalTrials.gov Identifier: NCT03238534     History of Changes
Other Study ID Numbers: ABO-NB-15
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action