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

NCT ID: NCT03883074

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2021-09-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

hyaluronic acid with chondroitin + sulphate + magnesium trisilicate

Intervention Type: DEVICE

Melt in mouth tablets (1100 mg)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

tablets with the same aspect of the active device

Interventions

hyaluronic acid with chondroitin + sulphate + magnesium trisilicate

Melt in mouth tablets (1100 mg)

Intervention Type: DEVICE

Placebo

tablets with the same aspect of the active device

Intervention Type: DEVICE

Other Intervention Names

GERDOff Plus; Placebo (for hyaluronic acid with chondroitin + sulphate + magnesium trisilicate)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SOFAR S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Tack, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

UZLeuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

PSC-DS TRIGERD 18

Identifier Type: -

Identifier Source: org_study_id