Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment

NCT04202692 | Completed

• 1 other identifier: PSC-DS MATRIX 19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This is a post-market, multi-center, double-blind, placebo-controlled, randomized, cross-over study with GERDOff Plus added on top of the current PPI treatment in patients with GERD. The aim of the study is to evaluate the performance of GERDOff Plus, a class III medical device, consisting in a hyaluronic acid, chondroitin sulphate and magnesium trisilicate, in addition to the PPIs, in patients with GERD not fully satisfied with their current treatment with PPIs. Patients will receive either GERDOff Plus or placebo q.i.d. for 21 days followed by a wash-out period of 3 weeks. After the wash-out period, the patients will receive either placebo or GERDOff Plus respectively

Conditions

Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Overall patient satisfaction

  The percentage of patients with an improvement of at least 2 points in the patient satisfaction measured with a 1 to 5 Likert scale (1 worst satisfaction, 5 best satisfaction)

  From baseline to the end of the respective 3-week treatment period

Secondary Outcomes (6)

• Change of weekly frequency of each symptom using the Gastro Esophageal Reflux Disease Questionnaire (GERDQ) questionnaire

  From baseline to the end of the respective 3-week treatment period

• Change of weekly global score of symptoms using the Gastro Esophageal Reflux Disease Questionnaire (GERDQ) questionnaire

  From baseline to the end of the respective 3-week treatment period

• Change of the intensity of each symptom using the Reflux Symptom Index (RSI) questionnaire

  From baseline to the end of the respective 3-week treatment period

• Change of the global score using the Reflux Symptom Index (RSI) questionnaire

  From baseline to the end of the respective 3-week treatment period

• Assessment of palatability

  At the end of 3-week treatment period

Study Arms (2)

GERDOff Plus

EXPERIMENTAL

Hyaluronic acid + 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 and magnesium trisilicate, 1100 mg melt in mouth tablet; Device: Placebo 1100 mg, identically-looking melt in mouth tablet

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: Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet; Device: Placebo 1100 mg, identically-looking melt in mouth tablet

Interventions

Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet DEVICE

1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks

Also known as: GERDOff Plus

GERDOff Plus; Placebo

Placebo 1100 mg, identically-looking melt in mouth tablet DEVICE

1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks

Also known as: GERDOff Plus placebo

GERDOff Plus; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent (ICF): a written informed consent must be obtained prior to any study related procedure being performed
• Male and female out-patients aged 18 to 80 years
• GERD diagnosis confirmed through a validated questionnaire (GERDQ score ≥ 8).
• EGD endoscopy performed within 1 year before screening
• Patients in continuous or intermittent treatment with PPI for at least 1 year and continuously for at least 4 weeks prior to study entry
• Patients not fully satisfied with current PPI treatment (1-3 score on 5-points Likert scale)

You may not qualify if:

• Dyspeptic patients or patients with overlapping symptoms with GI diseases other than GERD
• Histological evidence of Barrett's oesophagus \> 1 cm in EGD endoscopy
• Peptic stricture in EGD endoscopy
• Concurrent findings in the EGD endoscopy that might interfere with the participation to the study (e.g cancer, peptic ulcer) as judged by the investigator
• Known impaired kidney or liver function at screening
• Presence of any relevant severe condition or clinically relevant abnormal parameters that in the opinion of the investigator may interfere with the participation to the study
• Medication use (including H2 antagonists, alginates, baclofen, NSAIDS, prokinetics, antidepressants) 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 not employing adequate contraceptive methods
• Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable)
• 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

Sponsors & Collaborators

• SOFAR S.p.A.: lead

Study Sites (2)

Diakonie Klinikum GmbH - Jung- Stilling Krankenhaus

Siegen, North Rhine-Westphalia, 57074, Germany

Location

Klinikum Region Hannover (KRH) Klinikum Siloah

Hanover, 30459, Germany

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind, placebo controlled
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 17, 2019
• Study Start: November 5, 2019
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)