- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05060744
Efficacy and Speed of Action of a Product to Control Gastric Hydration and Gastroesophageal Reflux (AQUAA)
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna Fortuny
- Phone Number: +34 938 630 311
- Email: anna.fortuny@uriach.com
Study Contact Backup
- Name: Montse Vidal, Ph
- Phone Number: +34 663825890
- Email: montsevidal@crossdata.es
Study Locations
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Barcelona, Spain, 08008
- Recruiting
- Oriol Armengol
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Contact:
- Oriol Armengol, Ph
- Phone Number: +34 664 362 333
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention (Antacid)
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. |
The tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely.
Other Names:
|
Placebo Comparator: Control
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. |
The tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intensity of acidity/heartburn
Time Frame: At the beginning and at the end of treatment, an average of 7±1 days in patients
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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)
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At the beginning and at the end of treatment, an average of 7±1 days in patients
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Time from treatment intake to resolution or maximum decrease in acidity/heartburn
Time Frame: 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)
|
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
Time Frame: Baseline visit
|
Change in minutes of the time elapsed between product intake and intragastric pH > 4
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Baseline visit
|
Time with intragastric pH > 4 for 20 minutes before and after product intake
Time Frame: Baseline visit
|
Total time in minutes of the time in intragastric pH > 4 for 20 minutes before and after product intake
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Baseline visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic data
Time Frame: Baseline visit
|
Sex, ethnicity and age data of patients
|
Baseline visit
|
Time of tablet duration in the mouth before complete dissolution
Time Frame: At the beginning and at the end of treatment, an average of 7±1 days in patients
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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)
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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
Time Frame: An average of 7±1 days in patients
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Change in number of daytime and nightime episodes of acidity/heartburn (information recorded in the Patient Diary)
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An average of 7±1 days in patients
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Intensity of reflux before and after treatment
Time Frame: At the beginning and at the end of treatment, an average of 7±1 days in patients
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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
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Gastroesophageal Reflux Disease Questionnaire (GERD-Q) score
Time Frame: At the beginning and at the end of treatment, an average of 7±1 days in patients
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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.
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At the beginning and at the end of treatment, an average of 7±1 days in patients
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Number of Participants With Adverse Events
Time Frame: From the beginning to the end of treatment, an average of 7±1 days in patients
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Number of Participants With Adverse Events as a Measure of Safety and Tolerability
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From the beginning to the end of treatment, an average of 7±1 days in patients
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Degree of physician and patient satisfaction with the efficacy, rapidity of action and tolerability of the product
Time Frame: Through study completion, an average of 6 months
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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).
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Through study completion, an average of 6 months
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Mean intragastric pH
Time Frame: Baseline visit
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Change in mean intragastric pH for 20 minutes before and after product intake
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Baseline visit
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Number of episodes of GER (intraoesophageal pH < 4)
Time Frame: Baseline visit
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Change in the number of episodes of GER (intraoesophageal pH < 4).
Evaluation 20 minutes before and after taking the product
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Baseline visit
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Time with oesophageal pH < 4
Time Frame: Baseline visit
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Change in the time with oesophageal pH < 4. Evaluation 20 minutes before and after taking the product
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Baseline visit
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Longest reflux episode (oesophageal pH <4)
Time Frame: Baseline visit
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Change in the time of longest reflux episode (oesophageal pH <4).
Evaluation 20 minutes before and after taking the product
|
Baseline visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oriol Armengol, Ph, Primary Health Center Poblenou, Barcelona, Spain
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Dyskinesias
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Hyperkinesis
- Molecular Mechanisms of Pharmacological Action
- Gastrointestinal Agents
- Antacids
- Anti-Ulcer Agents
Other Study ID Numbers
- URI-AQUAA-2020-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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