Gastro Esophageal RefluxNCT03883074
Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease
A study testing hyaluronic acid with chondroitin + sulphate + magnesium trisilicate in people with Gastro Esophageal Reflux, run by SOFAR S.p.A. at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- hyaluronic acid with chondroitin + sulphate + magnesium trisilicate
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Dec 2018to 16 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- hyaluronic acid with chondroitin + sulphate + magnesium trisilicate, Placebo
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acid with chondroitin + sulphate + magnesium trisilicateDevice
Also called GERDOff Plus
Melt in mouth tablets (1100 mg)
PlaceboDevice
Also called Placebo (for hyaluronic acid with chondroitin + sulphate + magnesium trisilicate)
tablets with the same aspect of the active device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (7)
Esophageal acid exposure
Esophageal acid exposure assessed by 24-hour pH-impedance measurement
Measured: 3 weeks
Esophageal permeability
Esophageal permeability assessed by transepithelial electrical resistance
Measured: 3 weeks
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
Measured: 3 weeks
Intercellular spaces
The presence (on endoscopy) and severity of dilated intercellular spaces assessed by transmission electron microscopy.
Measured: 3 weeks
The expression of tight junctions
The expression of tight junction proteins at RNA, protein and immunohistochemistry level
Measured: 3 weeks
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
Measured: 3 weeks
Esophageal reflux episodes
Total number of reflux episodes and their proximal extent, number of acid reflux events and their duration.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start20 Dec 2018
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOFAR S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Tack, Prof., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883074
- Sponsor's protocol ID
- PSC-DS TRIGERD 18
- Status last verified
- May 2022
- First submitted
- 19 Mar 2019
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03883074
- Acronym / sponsor ID
- PSC-DS TRIGERD 18
- Conditions
- Gastro Esophageal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- SOFAR S.p.A.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GERDOff® Plus | Experimental | Device: hyaluronic acid with chondroitin + sulphate + magnesium trisilicatehyaluronic 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 | Placebo comparator | Device: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Patients suffering from gastrointestinal diseases other than GERD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronic acid with chondroitin + sulphate + magnesium trisilicateAlso: GERDOff PlusMelt in mouth tablets (1100 mg) | Device | GERDOff® Plus |
| PlaceboAlso: Placebo (for hyaluronic acid with chondroitin + sulphate + magnesium trisilicate)tablets with the same aspect of the active device | Device | Placebo |
Primary outcome
Esophageal Impedance
Time frame: 3 weeks
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.
7 secondary outcomes
Esophageal acid exposure
Time frame: 3 weeks
Esophageal permeability
Time frame: 3 weeks
Microscopic esophagitis
Time frame: 3 weeks
Intercellular spaces
Time frame: 3 weeks
The expression of tight junctions
Time frame: 3 weeks
ReQuest Questionnaire score
Time frame: 3 weeks
Esophageal reflux episodes
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack, Prof. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyaluronic acid with chondroitin + sulphate + magnesium trisilicate in people with Gastro Esophageal Reflux, run by SOFAR S.p.A. at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal Impedance (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.