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

NCT03883074 | Completed

• 1 other identifier: PSC-DS TRIGERD 18
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (1)

• 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.

  3 weeks

Secondary Outcomes (7)

• Esophageal acid exposure

  3 weeks

• Esophageal permeability

  3 weeks

• Microscopic esophagitis

  3 weeks

• Intercellular spaces

  3 weeks

• The expression of tight junctions

  3 weeks

Study Arms (2)

GERDOff® Plus

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

hyaluronic acid with chondroitin + sulphate + magnesium trisilicate DEVICE

Melt in mouth tablets (1100 mg)

Also known as: GERDOff Plus

GERDOff® Plus

Placebo DEVICE

tablets with the same aspect of the active device

Also known as: Placebo (for hyaluronic acid with chondroitin + sulphate + magnesium trisilicate)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SOFAR S.p.A.: lead

Study Sites (1)

UZLeuven

Leuven, box 701, 3000, Belgium

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jan Tack, Prof.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 20, 2019
• Study Start: December 20, 2018
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)