Efficacy and Speed of Action of a Product to Control Gastric Hydration and Gastroesophageal Reflux

Gastric Reflux Clinical Trial

— AQUAA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060744
• Other study ID #: URI-AQUAA-2020-01
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2022
• Source: Uriach Consumer Healthcare
• Contact: Anna Fortuny
• Phone: +34 938 630 311
• Email: anna.fortuny[@]uriach.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastric Reflux
• Gastroesophageal Reflux
• Hyperkinesis
• Oesophageal Reflux

Intervention

Device:
• Antacid
The tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely.

Other:
• Control
The tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely.

Locations

Country	Name	City	State
Spain	Oriol Armengol	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Uriach Consumer Healthcare

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity 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)	At the beginning and at the end of treatment, an average of 7±1 days in patients
Primary	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)	At the beginning and at the end of treatment, an average of 7±1 days in patients
Primary	Time elapsed between product intake and intragastric pH > 4	Change in minutes of the time elapsed between product intake and intragastric pH > 4	Baseline visit
Primary	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	Baseline visit
Secondary	Demographic data	Sex, ethnicity and age data of patients	Baseline visit
Secondary	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)	At the beginning and at the end of treatment, an average of 7±1 days in patients
Secondary	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)	An average of 7±1 days in patients
Secondary	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)	At the beginning and at the end of treatment, an average of 7±1 days in patients
Secondary	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.	At the beginning and at the end of treatment, an average of 7±1 days in patients
Secondary	Number of Participants With Adverse Events	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	From the beginning to the end of treatment, an average of 7±1 days in patients
Secondary	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).	Through study completion, an average of 6 months
Secondary	Mean intragastric pH	Change in mean intragastric pH for 20 minutes before and after product intake	Baseline visit
Secondary	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	Baseline visit
Secondary	Time with oesophageal pH < 4	Change in the time with oesophageal pH < 4. Evaluation 20 minutes before and after taking the product	Baseline visit
Secondary	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	Baseline visit