Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor

NCT ID: NCT03793556

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-05
• Study Completion Date: 2018-12-11

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.

Detailed Description

Cough, hoarseness, prolonged voice lowering, and vocal timbre modification, without any documentable cause, are considered as minor disorders for which patients do not receive adequate attention. These disorders may represent extra-esophageal manifestations of gastro-oesophagea reflux. Accurate diagnosis and gastro-oesophageal reflux therapy have been proved as useful to improve patients' quality of life.

The aim of the present study was to evaluate, in first diagnosed patients presenting with upper symptoms associated with GERD, the effect of a 6-week treatment with a combination based on CS, HA and aluminium hydroxide (Gerdoff®), co-administered with a treatment with PPIs, compared to treatment with PPIs as monotherapy, i.e. to verify, in patients treated with the combination of the two products, the reduction in symptoms frequency by means of a Likert questionnaire and the severity of upper symptoms by means of the Reflux Symptom Index (RSI) questionnaire, and to collect safety data. After 6 weeks of treatment, patients included in the two groups were then classified as responders or non-responders. Responder patients were defined as those patients that, at the 6th week of treatment, reached a RSI score decreased for at least 50% compared to baseline and an absolute value < 13.

Furthermore, the maintenance of the effect of treatment on the extra-oesophageal symptoms was evaluated after a period of follow-up lasting 12 weeks, which could be entered only by responder patients randomised in the Gerdoff®-PPI arm. Patients included in the follow-up period were randomised to receive Gerdoff® or no treatment (control group). Safety data were also evaluated in the group of patients that continued in the follow-up period.

Conditions

Gastro-oesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GERDOFF® + omeprazole

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).

Group Type: EXPERIMENTAL

GERDOFF® + Omeprazole

Intervention Type: 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).

Omeprazole

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

Group Type: ACTIVE_COMPARATOR

Omeprazole

Intervention Type: DRUG

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

Interventions

GERDOFF® + Omeprazole

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).

Intervention Type: DEVICE

Omeprazole

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

Intervention Type: DRUG

Other Intervention Names

GERDOFF®; Omeprazen

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects aged ≥ 18 years;

2. 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;

3. Presence of extra-oesophageal symptoms associated with GERD;

4. RSI score ≥ 20;

5. 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;

6. Cooperative patients, able to understand and adhere to the study procedures;

7. Patient able to freely give their written informed consent to study participation;

8. Patients that freely gave the consent to management of personal data related to the study.

Exclusion Criteria

1. Known infective oesophagitis or oesophagitis due to acid or alkaline substances;

2. Acute or chronic rhinosinusitis;

3. Chronic bronchitis;

4. Known Zollinger-Ellison syndrome, hiatal hernia greater than 3 cm and Barrett oesophagus;

5. Ongoing neoplasias;

6. Uncontrolled diabetes;

7. Patients with impaired liver function;

8. Patients with rare hereditary problems of galactose intolerance;

9. 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®);

10. Patients with deficiency of Lapp lactase;

11. Patients with syndrome of glu-gal malabsorption;

12. Patients with hypersensitivity to omeprazole, substitute benzymidazolic or any of the excipients;

13. Patients already in treatment with PPIs or similar products;

14. Chronic use of drugs that interfere with the salivary secretion (e.g. anti-histamines or inhaled steroids);

15. Abuse of drug or alcohol;

16. Inability of the subject to adequately express his/her disturbances;

17. Patients with planned or ascertained pregnancy or that did not adopt an accepted contraceptive method;

18. Lactating patients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SOFAR S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro Repici, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

dr Alessandro Repici

Rozzano, MI, Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PSC-DS GERD AP 16

Identifier Type: -

Identifier Source: org_study_id