AzTrials
AzTrials

Gastro Esophageal RefluxNCT04202692

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

A study testing Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet in people with Gastro Esophageal Reflux, run by SOFAR S.p.A. at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastro Esophageal Reflux
What is being tested?
Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
2 sitesGermany
Study dates
5 Nov 2019to 23 Nov 2022
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Klinikum Region Hannover (KRH) Klinikum Siloah

    Hanover, 30459

  • Diakonie Klinikum GmbH - Jung- Stilling Krankenhaus

    Siegen, North Rhine-Westphalia, 57074

Other trials in Germany

About this study

Official title: Evaluation of the Performance and Safety of an Oral Formulation of Hyaluronic Acid With Chondroitin Sulphate and Magnesium Trisilicate (GERDOff® Plus) in Patients With Gastro-Esophageal Reflux Disease: A Double-blind, Placebo-controlled, Randomized, Cross-over Study

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

Being tested
Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet, Placebo 1100 mg, identically-looking melt in mouth tablet
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 and magnesium trisilicate, 1100 mg melt in mouth tabletDevice

    Also called GERDOff Plus

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

  • Placebo 1100 mg, identically-looking melt in mouth tabletDevice

    Also called GERDOff Plus placebo

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

Study groups in NCT04202692
Study groupRoleWhat they receive
GERDOff PlusExperimentalHyaluronic 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.
Receives: 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
PlaceboPlacebo comparatorPlacebo 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: Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet; Device: Placebo 1100 mg, identically-looking melt in mouth tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (6)

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

    The reduction of weekly frequency score (points) for each symptom (score from 0 to 3, where higher scores mean a worse outcome) assessed by GERDQ questionnaire.

    Frequency score (points) for symptom: 0=0 day, 1=1 day, 2=2-3 days, 3=4-7 days;

    1. How often did you have a burning feeling behind your breastbone (heartburn)? 0 1 2 3
    2. How often did you have stomach contents (liquid or food) moving upwards to your throat or mouth (regurgitation)? 0 1 2 3
    3. How often did you have a pain in the centre of the upper stomach? 3 2 1 0
    4. How often did you have nausea? 3 2 1 0
    5. How often did you have difficulty getting a good night's sleep because of your heartburn and ⁄ or regurgitation? 0 1 2 3
    6. How often did you take additional medication for your heartburn and ⁄ or regurgitation, other than what the physician told you to take? (such as Tums, Rolaids, Maalox?) 0 1 2 3

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

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

    The reduction of global score of GERQ questionnaire (score from 0 to 18, where higher scores mean a worse outcome). Global score is obtained as sum score of the 6 items detailed in Outcome 2.

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

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

    The reduction of score of each symptom (from 0 to 5, where 0 = No problem and 5 = Severe Problem) assessed by RSI questionnaire

    1. Hoarseness or a problem with voice
    2. Cleaning throat
    3. Excess throat mucus or postnasal drip
    4. Difficulty swallowing food, liquids, or pills
    5. Coughing after eating or after lying down
    6. Breathing difficulties or chocking episodes
    7. Troublesome or annoying cough
    8. Sensations of something sticking or a lump in the throat
    9. Heartburn, chest pain, indigestion or stomach acid coming up

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

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

    The reduction of global score of RSI questionnaire (from 0 to 45, where higher scores mean a worse outcome). Global score is obtained as sum score of the 9 items detailed in Outcome 4.

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

  5. Assessment of palatability

    The score of taste through a 4-point qualitative scale (where 1 - taste as bad as possible, and 4 - taste as good as possible)

    Measured: At the end of 3-week treatment period

  6. Evaluation of the intake of rescue medications

    The amount of rescue medications taken

    Measured: From V1 (randomization) to V4 (Day 63 +/- 2 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2019
  2. Study start5 Nov 2019
  3. Primary completion23 Nov 2022
  4. Study completion23 Nov 2022

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04202692
Sponsor's protocol ID
PSC-DS MATRIX 19
Status last verified
Apr 2023
First submitted
12 Dec 2019
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet in people with Gastro Esophageal Reflux, run by SOFAR S.p.A. at 2 sites in Germany.

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 13 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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?

Overall patient satisfaction (time frame: From baseline to the end of the respective 3-week treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04202692.

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 12 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in