An interventional study of Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet and Placebo 1100 mg, identically-looking melt in mouth tablet in Gastro Esophageal Reflux, sponsored by SOFAR S.p.A.. Completed at 2 sites in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by SOFAR S.p.A. · Not applicable, Interventional, and Treatment
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
Exclusion Criteria:
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 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
1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks
Also known as: GERDOff Plus
1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks
Also known as: GERDOff Plus placebo
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)
Time frame: From baseline to the end of the respective 3-week treatment period
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
Time frame: 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
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.
Time frame: 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
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
Time frame: From baseline to the end of the respective 3-week treatment period
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.
Time frame: From baseline to the end of the respective 3-week treatment period
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)
Time frame: At the end of 3-week treatment period
Evaluation of the intake of rescue medications
The amount of rescue medications taken
Time frame: From V1 (randomization) to V4 (Day 63 +/- 2 days)
Plan to share: No
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SOFAR S.p.A.