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

NCT05060744 | Unknown

• 1 other identifier: URI-AQUAA-2020-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Oesophageal Reflux; Gastric Reflux; Hyperactivity; Stomach

Keywords

Oesophageal Reflux; Gastric Reflux; Hyperactivity; Stomach; Sodium Alginate; Calcium; Magnesium Salts; Hyaluronic Acid; Aloe Vera; Gastroenterology

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (11)

• Demographic data

  Baseline visit

• 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

• Number of daytime and nightime episodes of acidity/heartburn

  An average of 7±1 days in patients

• Intensity of reflux before and after treatment

  At the beginning and at the end of treatment, an average of 7±1 days in patients

• Gastroesophageal Reflux Disease Questionnaire (GERD-Q) score

  At the beginning and at the end of treatment, an average of 7±1 days in patients

Study Arms (2)

Intervention (Antacid)

ACTIVE COMPARATOR

An Antacid, a CE marked medical device under normal conditions of use. Sodium alginate (reduces reflux) (250 mg/tablet) Calcium carbonate (reduces acidity) (80 mg/tablet) Magnesium carbonate (reduces acidity) (144 mg/tablet) Hyaluronic acid (mucosal protector) (6.15 mg/tablet) Aloe vera extract without anthraquinones (mucosal protector) (40 mg/tablet) Patients should take 2 tablets of treatment at the time they develop reflux or hyperacidity. The maximum dose will be 6 tablets per day.

Device: Antacid

Control

PLACEBO COMPARATOR

The control will consist of a placebo based on excipients without active ingredients that will be formulated so that the tablet has the same appearance as the test product, with three different colour layers. Patients should take 2 tablets of treatment at the time they develop reflux or hyperacidity. The maximum dose will be 6 tablets per day.

Other: Control

Interventions

Antacid DEVICE

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

Also known as: Aquilea Antacid

Intervention (Antacid)

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uriach Consumer Healthcare: lead

Study Sites (1)

Oriol Armengol

Barcelona, 08008, Spain

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Spasm

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oriol Armengol, Ph

  Primary Health Center Poblenou, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Fortuny

CONTACT

+34 938 630 311; anna.fortuny@uriach.com

Montse Vidal, Ph

CONTACT

+34 663825890; montsevidal@crossdata.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clinical trial with CE marked medical device under normal conditions of use.

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 29, 2021
• Study Start: September 9, 2021
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 26, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)