Effect of a Combination Oral Formulation of Hyaluronic Ac... | NCT04202692

NCT04202692

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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; How often did you have a burning feeling behind your breastbone (heartburn)? 0 1 2 3 How often did you have stomach contents (liquid or food) moving upwards to your throat or mouth (regurgitation)? 0 1 2 3 How often did you have a pain in the centre of the upper stomach? 3 2 1 0 How often did you have nausea? 3 2 1 0 How often did you have difficulty getting a good night's sleep because of your heartburn and ⁄ or regurgitation? 0 1 2 3 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

Eligibility Module

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

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases