A Randomised, Placebo-Controlled Clinical Trial off the Efficacy and Rapidity of Action of a Product Containing Sodium Alginate, Calcium and Magnesium Salts, Hyaluronic Acid and Aloe Vera to Control Oesophageal-Gastric pH and Reduce Symptoms of Gastric Reflux and Hyperacidity.
The investigators will include patients with gastroesophageal reflux disease and heartburn (more than 3 weekly episodes of heartburn for at least 4 consecutive weeks) not related to medication intake and don't use proton pump blockers or H2-receptor antagonists. This is a multicentre clinical trial with two-phase design: Phase I: A double-blind, randomised, placebo-controlled clinical trial to assess the efficacy and rapidity of action of the medical device to reduce clinical symptoms of gastric reflux and hyperacidity under normal conditions of use. This phase I will be performed in primary care clinics. Phase II: A non-comparative, non-controlled clinical trial to objectively assess, using continuous pH monitoring, the magnitude and rapidity to control gastric and oesophageal pH after taking the product. This phase II will be performed at the Department of Gastroenterology of Medic Center. The study will begin with the baseline visit (day 0) in which the inclusion and exclusion criteria will be confirmed, the signing of informed consent will be obtained, GERD-Q Questionnaire will be done and treatment will be prescribed, followed by a home recording where patients will record data on episodes of acidity and heartburn occuring during the follow-up week. A face-to-face visit will be at 7 days after to recollect information about total number of daytime and nighttime episodes of acidity/heartburn since the previous visit and repeat the GERD-Q Questionnaire.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Oriol Armengol
Barcelona, Spain
RECRUITINGIntensity of acidity/heartburn
Change in intensity of acidity/heartburn before and after taking the treatment, assessed by the patient using a visual analogue scale (VAS from 0=none to 10=maximum imaginable)
Time frame: At the beginning and at the end of treatment, an average of 7±1 days in patients
Time from treatment intake to resolution or maximum decrease in acidity/heartburn
Change in time from treatment intake to resolution or maximum decrease in acidity/heartburn as assessed by the patient using a 3-point Likert scale (\<1 minute, 1-5 minutes, \>5 minutes)
Time frame: At the beginning and at the end of treatment, an average of 7±1 days in patients
Time elapsed between product intake and intragastric pH > 4
Change in minutes of the time elapsed between product intake and intragastric pH \> 4
Time frame: Baseline visit
Time with intragastric pH > 4 for 20 minutes before and after product intake
Total time in minutes of the time in intragastric pH \> 4 for 20 minutes before and after product intake
Time frame: Baseline visit
Demographic data
Sex, ethnicity and age data of patients
Time frame: Baseline visit
Time of tablet duration in the mouth before complete dissolution
Change in time of tablet duration in the mouth before complete dissolution, assessed using a 4-point Likert scale (\< 1 minute, 1-3 minutes, 3-5 min, \>5 minutes)
Time frame: At the beginning and at the end of treatment, an average of 7±1 days in patients
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Number of daytime and nightime episodes of acidity/heartburn
Change in number of daytime and nightime episodes of acidity/heartburn (information recorded in the Patient Diary)
Time frame: An average of 7±1 days in patients
Intensity of reflux before and after treatment
Change in intensity of reflux before and after treatment, assessed by the patient using a visual analogue scale (VAS from 0=none to 10=maximum imaginable)
Time frame: At the beginning and at the end of treatment, an average of 7±1 days in patients
Gastroesophageal Reflux Disease Questionnaire (GERD-Q) score
Change in Gastroesophageal Reflux Disease Questionnaire (GERD-Q) score. Between 0 and 8 in symptoms questions the score don't mean GERD, more than 8 mean GERD or severe GERD if in impact questions the score is more than 2.
Time frame: At the beginning and at the end of treatment, an average of 7±1 days in patients
Number of Participants With Adverse Events
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: From the beginning to the end of treatment, an average of 7±1 days in patients
Degree of physician and patient satisfaction with the efficacy, rapidity of action and tolerability of the product
Assessment of degree of physician and patient satisfaction with the efficacy, rapidity of action and tolerability of the product using 5-point Likert scales (0=very dissatisfied, 1=dissatisfied, 2=indifferent, 3=satisfied, 4=very satisfied).
Time frame: Through study completion, an average of 6 months
Mean intragastric pH
Change in mean intragastric pH for 20 minutes before and after product intake
Time frame: Baseline visit
Number of episodes of GER (intraoesophageal pH < 4)
Change in the number of episodes of GER (intraoesophageal pH \< 4). Evaluation 20 minutes before and after taking the product
Time frame: Baseline visit
Time with oesophageal pH < 4
Change in the time with oesophageal pH \< 4. Evaluation 20 minutes before and after taking the product
Time frame: Baseline visit
Longest reflux episode (oesophageal pH <4)
Change in the time of longest reflux episode (oesophageal pH \<4). Evaluation 20 minutes before and after taking the product
Time frame: Baseline visit