Oesophageal RefluxAQUAANCT05060744
Efficacy and Speed of Action of a Product to Control Gastric Hydration and Gastroesophageal Reflux
A study testing Antacid in people with Oesophageal Reflux and Gastric Reflux, run by Uriach Consumer Healthcare at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Reflux, Gastric Reflux, Hyperactivity; Stomach
- What is being tested?
- Antacid
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 9 Sep 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Oriol Armengol
Barcelona, 08008
Oriol Armengol, Ph, +34 664 362 333
About this study
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
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.
Read the 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.
- Conditions
- Oesophageal Reflux, Gastric Reflux, Hyperactivity; Stomach
- Being tested
- Antacid, Control
- Keywords
- Oesophageal Reflux, Gastric Reflux, Hyperactivity; Stomach, Sodium Alginate, Calcium, Magnesium Salts, Hyaluronic Acid, Aloe Vera, Gastroenterology
- Medical subject headings
- Gastroesophageal Reflux, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntacidDevice
Also called Aquilea Antacid
The tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely.
ControlOther
The tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline visit
Secondary outcomes (11)
Demographic data
Sex, ethnicity and age data of patients
Measured: Baseline visit
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)
Measured: 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
Change in number of daytime and nightime episodes of acidity/heartburn (information recorded in the Patient Diary)
Measured: An average of 7±1 days in patients
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)
Measured: At the beginning and at the end of treatment, an average of 7±1 days in patients
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.
Measured: At the beginning and at the end of treatment, an average of 7±1 days in patients
Number of Participants With Adverse Events
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: From the beginning to the end of treatment, an average of 7±1 days in patients
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).
Measured: Through study completion, an average of 6 months
Mean intragastric pH
Change in mean intragastric pH for 20 minutes before and after product intake
Measured: Baseline visit
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
Measured: Baseline visit
Time with oesophageal pH < 4
Change in the time with oesophageal pH < 4. Evaluation 20 minutes before and after taking the product
Measured: Baseline visit
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
Measured: Baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start9 Sep 2021
- Primary completion30 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial with CE marked medical device under normal conditions of use.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uriach Consumer Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oriol Armengol, Ph, Principal investigator, Primary Health Center Poblenou, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060744
- Sponsor's protocol ID
- URI-AQUAA-2020-01
- Acronym
- AQUAA
- Status last verified
- Oct 2022
- First submitted
- 17 Sep 2021
- Last updated
- 26 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05060744
- Acronym / sponsor ID
- AQUAA / URI-AQUAA-2020-01
- Conditions
- Oesophageal Reflux, Gastric Reflux, Hyperactivity; Stomach
- Keywords
- Oesophageal Reflux, Gastric Reflux, Hyperactivity; Stomach, Sodium Alginate, Calcium, Magnesium Salts, Hyaluronic Acid, Aloe Vera
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uriach Consumer HealthcareIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Clinical trial with CE marked medical device under normal conditions of use.
| Arm | Type | Receives |
|---|---|---|
| Intervention (Antacid) | Active comparator | Device: AntacidAn 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. |
| Control | Placebo comparator | Other: ControlThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntacidAlso: Aquilea AntacidThe tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely. | Device | Intervention (Antacid) |
| ControlThe tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely. | Other | Control |
Primary outcome
Intensity of acidity/heartburn
Time frame: 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
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)
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
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
11 secondary outcomes
Demographic data
Time frame: 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
Number of daytime and nightime episodes of acidity/heartburn
Time frame: An average of 7±1 days in patients
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
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
Number of Participants With Adverse Events
Time frame: From the beginning to the end of treatment, an average of 7±1 days in patients
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
Mean intragastric pH
Time frame: Baseline visit
Number of episodes of GER (intraoesophageal pH < 4)
Time frame: Baseline visit
Time with oesophageal pH < 4
Time frame: Baseline visit
Longest reflux episode (oesophageal pH <4)
Time frame: Baseline visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oriol Armengol, Ph principal investigator
Primary Health Center Poblenou, Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antacid in people with Oesophageal Reflux and Gastric Reflux, run by Uriach Consumer Healthcare at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Fortuny (+34 938 630 311, anna.fortuny@uriach.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of acidity/heartburn (time frame: At the beginning and at the end of treatment, an average of 7±1 days in patients). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.