Condition category
Digestive System
Date applied
15/12/2017
Date assigned
19/12/2017
Last edited
18/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Gastroesophageal reflux (English acronym GERD, Gastro-Oesophageal Reflux Disease) is caused by a functional defect in the oesophagus and is characterized by the reflux of stomach contents and of gases produced in the intestine into the oesophagus, generating a reflux of acid material. The GERD symptoms include burning chest, acid and alkaline regurgitation from lying down, stomach cramps, and difficulty in swallowing. Some people have gastric reflux which is not cured by other drugs. In this study we evaluate if GERDOFF tablets can be helpful to reduce gastric reflux and heartburn.

Who can participate?
Adults aged 18 and older who have gastric reflux.

What does the study involve?
All participants receive GERDOFF tablets for two weeks after meals and before bedtime. Participants are followed up to see if they

What are the possible benefits and risks of participating?
The possible benefits are symptoms alleviation and improvement of quality of life; the main potential risk is that the device does not work. Side effects to treatement are not expected since the product is already commercially available.

Where is the study run from?
The University of Modena (Italy) and the Hospital of Cernusco sul Naviglio (Italy) are the centres taking part in this trial. The University of Modena is the lead centre.

When is study starting and how long is it expected to run for?
The study started in 2014 and is currently completed.

How long will the trial be recruiting participants for?
SOFAR Spa (Italy)

Who is the main contact?
Dr Alberto Merighi merighi.alberto@policlinico.mo.it

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alberto Merighi

ORCID ID

Contact details

via del Pozzo 71
Modena
41124
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RE-GERD 14

Study information

Scientific title

Exploratory, post-market, open-label clinical investigation to evaluate the effect of the medical device, GERDOFF® melt-in-mouth tablets, in patients with GERD and with reduced effect or ineffectiveness of alginates treatment.

Acronym

GERDOFF® efficacy in patients with GERD

Study hypothesis

The purpose of this exploratory clinical investigation is to evaluate the effect of GERDOFF® in reducing the number of “heartburn” episodes, GERD symptom manifestation, per week, after 14 days of treatment, by assessing the number of days with the symptom "heartburn" over the last week of treatment compared to baseline.

Ethics approval

1. Azienda Ospedaliero-Universitaria Policlinico di Modena (University Hospital of Modena), 08/10/2014, Substantial Amendment version 2.0 was acknowledged by EC on 04/06/2015, ref: 137.14
2. For Substantial Amendment version 2.0 by Comitato Etico Interaziendale Area A Milano (Ethics Commitee Intercompany Area A Milan), 24/06/2015

Study design

Post-marketing exploratory open-label two sites clinical study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Gastroesophageal reflux

Intervention

All patients are trained to take 4 melt-in -mouth tablets containing high molecular weight hyaluronic acid, aluminum hydroxide, and chondroitin sulphate (GERDOFF® 1100 mg; SOFAR S.p.A., Trezzano Rosa, Milan, Italy) after meals and before bedtime, for 14 days.

Participants are followed up to see if there is a reduction in the number of heartburn episodes per week and the frequency of their symptoms.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Reduction in the number of heartburn episodes per week is measured using patient diaries at baseline, day 7 and day 14.

Secondary outcome measures

1. Frequency of GERD- related symptoms are measured using patient diaries and the GIS Gerd impact scale questionnaire at baseline, day 7 and 14
2. Patient satisfaction is measured using GIS Gerd impact scale questionnaire at baseline, day 7 and day 14
3. Number of days without symptoms are measured using patient diaries at baseline, day 7 and day 14
4. Patient’s compliance to the therapy is measured using patient diaries at baseline, day 7 and day 14

Overall trial start date

30/05/2014

Overall trial end date

20/06/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥18 years
2. Having symptoms associated to diagnosis of GERD, performed on clinical basis with the presence of following symptoms
2.1. Heartburn and/or regurgitation, diurnal and/or nocturnal, of moderate intensity, at least twice a week, for at least two weeks, disturbing the patient during normal activities and/or in the recovery of night-time sleep, whether or not accompanied by other symptoms
3. Having a medical report of EGDS performed within 3 months prior to the study start, excluding other diseases in the upperpart of the digestive system (e.g. erosion/ulcer gastric or duodenal)
4. Responding to PPI treatment during the 6 months prior to the study start
5. Having a disease not controlled by alginate treatment, taken on the basis of the dosage recommendations given in the leaflet for at least 2 weeks prior to study initiation
6. Being able to understand and comply with the study procedures
7. Being able to provide a written informed consent to participate into the study
8. Being able to provide a consent to the processing of personal data related to the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 patients

Participant exclusion criteria

1. Known esophagitis caused by infection or by acid or alkaline substances
2. Treatment for eradication of Helicobacter Pylori (HP) in the 30 days prior to informed consent signature
3. Concomitant PPI therapy, if not already in use in the 2 weeks prior to V0
4. Expected alginates intake during the study
5. Patients, who planned to use during the course of the study anti-acids, prokinetics, anti-H2, or other pharmaceutical products and/or over-the-counter products and/or medical devices indicated for the treatment of GERD, will not be included
6. History of Zollinger-Ellison syndrome, hiatal hernia and Barrett's oesophagus
7. Known diabetes
8. Inability of the patient to adequately describe his/ her disorders
9. Unauthorized consent to the processing of personal data
10. Planned or known pregnancy
11. Breastfeeding
12. Participation in other clinical trials/investigations with drugs or experimental products within 3 months prior to enrolment

Recruitment start date

18/12/2014

Recruitment end date

30/01/2017

Locations

Countries of recruitment

Italy

Trial participating centre

Azienda Ospedaliero-Universitaria
Modena
41124
Italy

Trial participating centre

Presidio Ospedaliero
Cernusco sul Naviglio
20063
Italy

Sponsor information

Organisation

Sofar Spa

Sponsor details

Via Firenze
40
Trezzano Rosa
20060
Italy

Sponsor type

Industry

Website

http://www.sofarfarm.it/

Funders

Funder type

Industry

Funder name

Sofar Spa

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

An article on this study is already ready to be submitted to scientific journals. The protocol and the statistical analysis plan have not been published online. The study was completed in 2017.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Alberto Merighi merighi.alberto@policlinico.mo.it. Data that will be available will be vital the responses of GIS questionnaire, for 5 years from publication. Data will be accessible for anyone who wish to perform individual patient data metanalysis. Proposals should be directed to dr Merighi Alberto. Data will be anonimyzed before sharing.

Intention to publish date

01/03/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes