Oesophageal Reflux, Gastric Reflux, Hyperactivity; Stomach
Conditions
Keywords
Oesophageal Reflux, Gastric Reflux, Hyperactivity; Stomach, Sodium Alginate, Calcium, Magnesium Salts, Hyaluronic Acid, Aloe Vera, Gastroenterology
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAntacid
The tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely.
OTHERControl
The tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely.
Sponsors
Uriach Consumer Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Clinical trial with CE marked medical device under normal conditions of use.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of both sexes over 18 years of age * 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 * Patients not on proton pump blockers or H2-receptor antagonists * Patients able to understand the study implications and who sign the informed consent.
Exclusion criteria
* Pregnant or nursing women * Patients who are currently using or have used other medications or antacid products for the treatment of reflux and hyperacidity symptoms within 7 days prior to enrolment in this study. * Patients treated with antihypertensive drugs, calcium channel blockers or non-steroidal anti-inflammatory drugs (NSAIDs) * Patients with hypercalcaemia, hypertension, renal failure or other conditions in which the use of the components of the investigational product is not recommended. * Patients with serious diseases that, in the physician's opinion, could interfere with the results of the study or prevent their participation in it.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of acidity/heartburn | At the beginning and at the end of treatment, an average of 7±1 days in patients | 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 from treatment intake to resolution or maximum decrease in acidity/heartburn | At the beginning and at the end of treatment, an average of 7±1 days in patients | 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 elapsed between product intake and intragastric pH > 4 | Baseline visit | Change in minutes of the time elapsed between product intake and intragastric pH \> 4 |
| Time with intragastric pH > 4 for 20 minutes before and after product intake | Baseline visit | Total time in minutes of the time in intragastric pH \> 4 for 20 minutes before and after product intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographic data | Baseline visit | Sex, ethnicity and age data of patients |
| Time of tablet duration in the mouth before complete dissolution | At the beginning and at the end of treatment, an average of 7±1 days in patients | 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) |
| Number of daytime and nightime episodes of acidity/heartburn | An average of 7±1 days in patients | Change in number of daytime and nightime episodes of acidity/heartburn (information recorded in the Patient Diary) |
| Intensity of reflux before and after treatment | At the beginning and at the end of treatment, an average of 7±1 days in patients | 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) |
| Gastroesophageal Reflux Disease Questionnaire (GERD-Q) score | At the beginning and at the end of treatment, an average of 7±1 days in patients | 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. |
| Number of Participants With Adverse Events | From the beginning to the end of treatment, an average of 7±1 days in patients | Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
| Degree of physician and patient satisfaction with the efficacy, rapidity of action and tolerability of the product | Through study completion, an average of 6 months | 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). |
| Mean intragastric pH | Baseline visit | Change in mean intragastric pH for 20 minutes before and after product intake |
| Number of episodes of GER (intraoesophageal pH < 4) | Baseline visit | Change in the number of episodes of GER (intraoesophageal pH \< 4). Evaluation 20 minutes before and after taking the product |
| Time with oesophageal pH < 4 | Baseline visit | Change in the time with oesophageal pH \< 4. Evaluation 20 minutes before and after taking the product |
| Longest reflux episode (oesophageal pH <4) | Baseline visit | Change in the time of longest reflux episode (oesophageal pH \<4). Evaluation 20 minutes before and after taking the product |
Countries
Spain
Contacts
Primary ContactAnna Fortuny
Backup ContactMontse Vidal, Ph
Outcome results
None listed