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

Primary Purpose

Gastro Esophageal Reflux

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
hyaluronic acid with chondroitin + sulphate + magnesium trisilicate
Placebo
Sponsored by
SOFAR S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastro Esophageal Reflux

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZLeuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GERDOff® Plus

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Esophageal Impedance
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.

Secondary Outcome Measures

Esophageal acid exposure
Esophageal acid exposure assessed by 24-hour pH-impedance measurement
Esophageal permeability
Esophageal permeability assessed by transepithelial electrical resistance
Microscopic esophagitis
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
Intercellular spaces
The presence (on endoscopy) and severity of dilated intercellular spaces assessed by transmission electron microscopy.
The expression of tight junctions
The expression of tight junction proteins at RNA, protein and immunohistochemistry level
ReQuest Questionnaire score
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
Esophageal reflux episodes
Total number of reflux episodes and their proximal extent, number of acid reflux events and their duration.

Full Information

First Posted
March 19, 2019
Last Updated
May 5, 2022
Sponsor
SOFAR S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03883074
Brief Title
Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
September 16, 2021 (Actual)
Study Completion Date
September 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOFAR S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GERDOff® Plus
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
hyaluronic acid with chondroitin + sulphate + magnesium trisilicate
Other Intervention Name(s)
GERDOff Plus
Intervention Description
Melt in mouth tablets (1100 mg)
Intervention Type
Device
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo (for hyaluronic acid with chondroitin + sulphate + magnesium trisilicate)
Intervention Description
tablets with the same aspect of the active device
Primary Outcome Measure Information:
Title
Esophageal Impedance
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Esophageal acid exposure
Description
Esophageal acid exposure assessed by 24-hour pH-impedance measurement
Time Frame
3 weeks
Title
Esophageal permeability
Description
Esophageal permeability assessed by transepithelial electrical resistance
Time Frame
3 weeks
Title
Microscopic esophagitis
Description
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
Time Frame
3 weeks
Title
Intercellular spaces
Description
The presence (on endoscopy) and severity of dilated intercellular spaces assessed by transmission electron microscopy.
Time Frame
3 weeks
Title
The expression of tight junctions
Description
The expression of tight junction proteins at RNA, protein and immunohistochemistry level
Time Frame
3 weeks
Title
ReQuest Questionnaire score
Description
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
Time Frame
3 weeks
Title
Esophageal reflux episodes
Description
Total number of reflux episodes and their proximal extent, number of acid reflux events and their duration.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, Prof.
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZLeuven
City
Leuven
ZIP/Postal Code
box 701, 3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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