Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease

May 5, 2022 updated by: SOFAR S.p.A.

Effect of a Combination Oral Formulation of Hyaluronic Acid With Chondroitin Sulphate and With Magnesium Trisilicate on Mucosal Integrity and Reflux Exposure in Subjects With Gastro-Esophageal Reflux Disease Not Currently Treated With a Proton Pump Inhibitor: a Double-Blind, Placebo-Controlled, Randomized, Crossover Study

The aim of this study is to investigate whether a 3-week treatment with an oral melt in mouth medical device, made up with hyaluronic acid, chondroitin sulphate and magnesium trisilicate, can lead to a reduction of Gastroesophageal Reflux Disease symptoms and to an improvement of the integrity of esophageal mucosa in patients who are to experiencing esophagus symptoms. The study is a randomized, double-blind cross-over placebo controlled study. Every patient will get both the active study device during one study period and placebo during another another period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, box 701, 3000
        • UZLeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females, age 18 to 75 years
  • GERD as defined by an acid exposure time >4% on pH/impedance monitoring and/or esophagitis LA grade A or B on endoscopy
  • Heartburn at least twice per week over the last 1 month
  • ReQuest Symptoms sum score >3,37 at screening
  • GERD patients not treated with a PPI in the previous 2 months
  • Subjects capable of understanding and be willing to provide signed and dated written voluntary informed consent

Exclusion Criteria:

  • Patients suffering from gastrointestinal diseases other than GERD

    • Esophagitis LA grade C or D or Barrett's esophagus on endoscopy
    • Impaired kidney or liver function
    • Significant cardiac, pulmonary or psychiatric comorbidity as judged by the investigator
    • Medication use (including NSAIDS) that may interfere with GERD symptom assessment within 2 weeks before the start of the study or during the study
    • Pregnancy or breast-feeding
    • Females of childbearing potential in the absence of effective contraceptive methods
    • History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent
    • History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements
    • Treatment with any investigational drug within the previous 30 days
    • Active malignancy of any type, or history of cancer, including solid tumors and hematological malignancies (except patients with malignancies that have been surgically removed and/or with no evidence of recurrence for at least five years before study enrolment)
    • Inability to conform to protocol procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GERDOff® Plus
hyaluronic acid with chondroitin + sulphate + magnesium trisilicate Melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks. After three weeks of wash-out period,patients will take either placebo or GERDOff® Plus q.i.d. (three after meals, one before resting) for another three weeks.
Device: hyaluronic acid with chondroitin + sulphate + magnesium trisilicate
Melt in mouth tablets (1100 mg)
Other Names:
  • GERDOff Plus
Placebo Comparator: Placebo
Placebo melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for three consecutive weeks. After three weeks of wash-out period,patients will take either placebo or GERDOff® Plus q.i.d. (three after meals, one before resting) for another three weeks.
Device: Placebo
tablets with the same aspect of the active device
Other Names:
  • Placebo (for hyaluronic acid with chondroitin + sulphate + magnesium trisilicate)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Esophageal Impedance
Time Frame: 3 weeks
Change between groups in baseline impedance value. Impedance baseline values will be assessed in two steady periods of 30 seconds at the beginning and at the end of consecutive time windows of 30 minutes, 60 minutes.
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Esophageal acid exposure
Time Frame: 3 weeks
Esophageal acid exposure assessed by 24-hour pH-impedance measurement
3 weeks
Esophageal permeability
Time Frame: 3 weeks
Esophageal permeability assessed by transepithelial electrical resistance
3 weeks
Microscopic esophagitis
Time Frame: 3 weeks
Microscopic esophagitis evidence at endoscopy assessed by Esohisto score. The score assesses the severity of esophagitis through a score for each parameter ranging from 0 to 2 (0=normal, 2=severe). Parameters are: Basal cell layer hyperplasia; Papillary elongation; Dilated intercellular spaces; Intraepithelial eosinophils; Intraepithelial neutrophils; Intraepithelial mononuclear cells
3 weeks
Intercellular spaces
Time Frame: 3 weeks
The presence (on endoscopy) and severity of dilated intercellular spaces assessed by transmission electron microscopy.
3 weeks
The expression of tight junctions
Time Frame: 3 weeks
The expression of tight junction proteins at RNA, protein and immunohistochemistry level
3 weeks
ReQuest Questionnaire score
Time Frame: 3 weeks
Change in ReQuest score for GERD symptoms severity evaluated through ReQuest Questionnaire. ReQuest is a self-assessed, dimension-orientated scale designed to evaluate the treatment response in patients suffering from erosive GERD. It assesses seven dimensions of GERD (acid complaints, upper abdominal/stomach complaints, lower abdominal/ digestive complaints, nausea, sleep disturbances, other complaints and general well-being). The intensity is measured on a 100-mm visual analogue scale and the frequency (except general well-being) on a 7-point Likert scale, ranging from 0 to more than 10 times per day. It asks for the occurrence of symptom descriptions known to be typical of the corresponding dimension
3 weeks
Esophageal reflux episodes
Time Frame: 3 weeks
Total number of reflux episodes and their proximal extent, number of acid reflux events and their duration.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SOFAR S.p.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan Tack, Prof., Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSC-DS TRIGERD 18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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