Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor

NCT03793556 | Completed Results

• 1 other identifier: PSC-DS GERD AP 16
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study was to evaluate the effect of a 6-weeks treatment of a CE-marked combination oral formulation of hyaluronic acid with chondroitin sulphate and aluminium hydroxide (GERDOFF®), in addition to proton pump inhibitors (PPI) at the standard dose, versus PPI only, in patients with first diagnosed clinical presentation of extra-esophageal GERD symptoms. The investigators verified the reduction of symptoms frequency, using a Likert questionnaire, and severity, using the Reflux Symptom Index (RSI) questionnaire, to evaluate the proportion of Responders and Non-Responder patients in these two groups after 6 weeks of treatment, compared to baseline. Moreover investigators evaluated the persistence of effects of GERDOFF® + PPI treatment on extraesophageal symptoms, after a 12-weeks follow up, only in responder patients.

Conditions

Gastro-oesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire

  After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).

  In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)

Secondary Outcomes (18)

• Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed

  In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment)

• Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4

  At baseline and in the visit 4, after 6 weeks of treatment

• Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance

  At baseline and in the visit 4, after 6 weeks of treatment

• Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4

  At baseline and in the visit 4, after 6 weeks of treatment

• Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4

  At baseline and in the visit 4, after 6 weeks of treatment

Study Arms (2)

GERDOFF® + omeprazole

EXPERIMENTAL

GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).

Device: GERDOFF® + Omeprazole

Omeprazole

ACTIVE COMPARATOR

Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).

Drug: Omeprazole

Interventions

GERDOFF® + Omeprazole DEVICE

GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg + Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).

Also known as: GERDOFF®

GERDOFF® + omeprazole

Omeprazole DRUG

Omeprazole, 2 capsules 20 mg, once a day before breakfast

Also known as: Omeprazen

Omeprazole

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged ≥ 18 years;
• First diagnosis of GERD with upper symptoms, made on a clinical basis and confirmed by an ENT and/or confirmed by a Gastroenterologist using a RSI questionnaire;
• Presence of extra-oesophageal symptoms associated with GERD;
• RSI score ≥ 20;
• Patients not pre-treated with PPIs, even for problems different from GERD, and/or with medical devices and/or similar products (e.g. antacid alginates etc..) in the last 4 weeks;
• Cooperative patients, able to understand and adhere to the study procedures;
• Patient able to freely give their written informed consent to study participation;
• Patients that freely gave the consent to management of personal data related to the study.

You may not qualify if:

• Known infective oesophagitis or oesophagitis due to acid or alkaline substances;
• Acute or chronic rhinosinusitis;
• Chronic bronchitis;
• Known Zollinger-Ellison syndrome, hiatal hernia greater than 3 cm and Barrett oesophagus;
• Ongoing neoplasias;
• Uncontrolled diabetes;
• Patients with impaired liver function;
• Patients with rare hereditary problems of galactose intolerance;
• Patients that, based on Investigator's opinion, could not take part in the study due to other diseases or concomitant therapies, such as the intake of atazanavir, nelfinavir, clopidogrel, posaconazole and erlotinib (as recommended in the Summary of Product Characteristics of Gerdoff®);
• Patients with deficiency of Lapp lactase;
• Patients with syndrome of glu-gal malabsorption;
• Patients with hypersensitivity to omeprazole, substitute benzymidazolic or any of the excipients;
• Patients already in treatment with PPIs or similar products;
• Chronic use of drugs that interfere with the salivary secretion (e.g. anti-histamines or inhaled steroids);
• Abuse of drug or alcohol;

Sponsors & Collaborators

• SOFAR S.p.A.: lead

Study Sites (1)

dr Alessandro Repici

Rozzano, MI, 20089, Italy

Location

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

Results Point of Contact

• Title: Dr Francesca Baldan
• Organization: Sofar Spa

francesca.baldan@sofarfarm.it

0039 02 909362

Study Officials

• Alessandro Repici, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients was randomized in an open-label treatment (in a ratio 1:1) and treated with the investigational medical device (IMD) + proton pump inhibitor (PPI) or PPI only for 6 weeks. At the end of treatment visit (V4) only patients who were classified as responders and belonging to the GERDOFF®+PPI group were included in the follow-up phase for 12 further weeks. During the follow-up, patients were randomized to an open-label treatment (in a 1:1 ratio) to GERDOFF® group or control group that will not receive any treatment for 12 weeks in order to evaluate the maintenance of treatment effects. To safeguard the health and well-being of patients, and to keep under control the possible upper symptoms of GERD that could appear, all patients that continued in the follow-up period received omeprazole as rescue medication, in a quantity adequate to cover the entire follow-up period.

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: January 4, 2019
• Study Start: May 5, 2017
• Primary Completion: September 20, 2018
• Study Completion: December 11, 2018
• Last Updated: March 31, 2020
• Results First Posted: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)