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

NCT ID: NCT04202692

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2022-11-23

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

Study Design

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

Study Groups

GERDOff Plus

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Placebo 1100 mg, identically-looking melt in mouth tablet

Intervention Type: DEVICE

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

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

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

Intervention Type: DEVICE

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

Placebo 1100 mg, identically-looking melt in mouth tablet

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Placebo 1100 mg, identically-looking melt in mouth tablet

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

Intervention Type: DEVICE

Other Intervention Names

GERDOff Plus; GERDOff Plus placebo

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SOFAR S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Diakonie Klinikum GmbH - Jung- Stilling Krankenhaus

Siegen, North Rhine-Westphalia, Germany

Klinikum Region Hannover (KRH) Klinikum Siloah

Hanover, , Germany

Countries

Germany

Other Identifiers

PSC-DS MATRIX 19

Identifier Type: -

Identifier Source: org_study_id