Clinical trial NCT05060744: Efficacy and Speed of Action of a Product to Control Gastric Hydration and Gastroesophageal Reflux
Official title: Study Off Efficacy and Rapidity of Action of a Product With Sodium Alginate, Calcium and Magnesium Salts, Hyaluronic Acid and Aloe Vera to Control Oesophageal-Gastric Acidity (pH), Symptoms of Gastric Reflux and Hyperacidity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oesophageal Reflux
Gastric Reflux
Hyperactivity; Stomach
Keywords: Oesophageal Reflux
Gastric Reflux
Hyperactivity; Stomach
Sodium Alginate
Calcium
Magnesium Salts
Hyaluronic Acid
Aloe Vera
Gastroenterology
Lead sponsor: Uriach Consumer Healthcare
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial with CE marked medical device under normal conditions of use.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intensity of acidity/heartburn
timeFrame: At the beginning and at the end of treatment, an average of 7±1 days in patients
measure: Time from treatment intake to resolution or maximum decrease in acidity/heartburn
timeFrame: At the beginning and at the end of treatment, an average of 7±1 days in patients
measure: Time elapsed between product intake and intragastric pH > 4
timeFrame: Baseline visit
measure: Time with intragastric pH > 4 for 20 minutes before and after product intake
timeFrame: Baseline visit
Secondary outcomes:
measure: Demographic data
timeFrame: Baseline visit
measure: Time of tablet duration in the mouth before complete dissolution
timeFrame: At the beginning and at the end of treatment, an average of 7±1 days in patients
measure: Number of daytime and nightime episodes of acidity/heartburn
timeFrame: An average of 7±1 days in patients
measure: Intensity of reflux before and after treatment
timeFrame: At the beginning and at the end of treatment, an average of 7±1 days in patients
measure: Gastroesophageal Reflux Disease Questionnaire (GERD-Q) score
timeFrame: At the beginning and at the end of treatment, an average of 7±1 days in patients
measure: Number of Participants With Adverse Events
timeFrame: From the beginning to the end of treatment, an average of 7±1 days in patients
measure: Degree of physician and patient satisfaction with the efficacy, rapidity of action and tolerability of the product
timeFrame: Through study completion, an average of 6 months
measure: Mean intragastric pH
timeFrame: Baseline visit
measure: Number of episodes of GER (intraoesophageal pH < 4)
timeFrame: Baseline visit
measure: Time with oesophageal pH < 4
timeFrame: Baseline visit
measure: Longest reflux episode (oesophageal pH <4)
timeFrame: Baseline visit
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Oriol Armengol
Study officials:
affiliation: Primary Health Center Poblenou, Barcelona, Spain
name: Oriol Armengol, Ph
role: PRINCIPAL_INVESTIGATOR
References: