Gastroesophageal Reflux DiseasePhase 2/3NCT03516188
Efficacy of Gaviscon-Advance® in Suppressing Post-supper Acid-pocket and Night-time Acid-reflux in Obese Participants
A Phase 2/3 study testing Alginate-antacid group and Non antacid alginate group in people with Gastroesophageal Reflux Disease and Acid Reflux, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
A randomized, open-label study with antacid-control will be performed over 48 hours period by continuous pH impedance and bravo capsule monitoring. Asymptomatic obese patients will be separated into either groups according to alginate antacid group [Gaviscon Advance (GA)®, Reckitt Benckiser, UK] and non antacid… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease, Acid Reflux, Obesity
- What is being tested?
- Alginate-antacid group and Non antacid alginate group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMalaysia
- Study dates
- Jul 2016to Jun 2017
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged greater than or equal to 18 years and less than or equal to 70 years.
- BMI >27.5 (based on kg/m2)
- 4. Not taking acid suppressant PPI and H2 receptor blockers 5. Not taking antacids or alginate preparations, except those administered as part of study procedure.
Who cannot join
- Those with gastrointestinal symptoms indicative of GERD, gastric carcinoma, previous or current peptic ulcer disease.
- Those with a history of upper GI surgery prior to this.
- Those with haematological disorders, bleeding tendency, recurrent nose bleeds or treatment with anti-coagulants).
- Those who had any previous history of allergy or known intolerance to any of the study drugs or the following formulation constituents: Gaviscon® liquid: sodium alginate, sodium bicarbonate and calcium carbonate
- Those with physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospitial Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
About this study
Official title: Open-label Antacid-controlled Randomized Study on Effectiveness of Alginate-antacid Preparation (Gaviscon-Advance®) in Suppression of Post-supper Acid-pocket, Night-time Acid-reflux and Symptoms in Obese Participants
A randomized, open-label study with antacid-control will be performed over 48 hours period by continuous pH impedance and bravo capsule monitoring. Asymptomatic obese patients will be separated into either groups according to alginate antacid group [Gaviscon Advance (GA)®, Reckitt Benckiser, UK] and non antacid alginate group [simple antacid]. Both groups will be studied for 48 hours using the ambulatory wireless capsule and pH impedance. Participants according to their group will take either alginate antcid [Gaviscon Advance (GA)®, Reckitt Benckiser, UK] or non alginate antacid [simple antacid] which has equivalent strength of antacid after taking late night standardised meals.
Read the detailed description
Gastroesophageal reflux disease (GERD) with symptoms of heartburn and acid regurgitation is a common disorder especially in overweight and obese persons who are at increased risk for GERD. Late night supper, an usual eating habit in many parts of the world, may worsen GERD and especially so among the obese, and this may be due to increased reflux from acid pocket.
Acid pocket in the proximal part of stomach after meals has been shown to be an important mechanism of GERD. The acid pocket is increasingly recognized as a source from which acid reflux events originate. To what extent changes in acidity of the acid pocket contribute to the therapeutic effect of alginate antacid formulation is inconsistent. The other findings suggested that the main mechanism of action for the alginate-antacid combination is to displace the post-prandial acid pocket rather than mechanically containing it.
Therefore, the outcomes of the study will allow us to determine whether late night supper worsen acid pocket, night time reflux and symptoms and whether an alginate antacid preparation (Gaviscon Advance®) is useful in suppression of acid pocket, night time refluxes and symptom (s). A benefit is that this study may inform doctors and advise participants of GERD side-effects of late night supper and how Gaviscon Advance may help.
- Conditions
- Gastroesophageal Reflux Disease, Acid Reflux, Obesity
- Being tested
- Alginate-antacid group, Non antacid alginate group
- Keywords
- Gastroesophageal Reflux Disease, Acid pocket, Acid Reflux, Alginate antacid, Obesity
- Medical subject headings
- Gastroesophageal Reflux, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alginate-antacid groupDrug
Also called Gaviscon-Advance®
Participants will be given 10 mL of alginate-antacid preparation (Gaviscon-Advance®, Reckitt-Benckiser, United Kingdom)
Non antacid alginate groupDrug
Also called Magnesium tri-silicate
Participants will be given 4 mL of magnesium tri-silicate which has equivalent strength and component with Gaviscon-Advance® except it is alginate-free.
| Study group | Role | What they receive |
|---|---|---|
| Alginate-antacid group | Experimental | Participants will take normal meals with late night supper (i.e.two chicken burgers and one cup or 250 ml of teh-tarik) plus alginate-antacid. Receives: Drug: Alginate-antacid group |
| Non antacid alginate group | Experimental | Participants will take normal meals with late night supper (i.e.two chicken burgers and one cup or 250 ml of teh-tarik) plus antacid alone. Receives: Drug: Non antacid alginate group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of acid-pocket
Duration of acid-pocket will be assessed using Bravo capsules. The unit of measure is in minutes.
Measured: 48 hours
Secondary outcomes (3)
Symptom response
Symptom response will be assessed using visual analogue scale (0 - 10).
Measured: 48 hours
Acidity of acid-pocket
Acidity of acid-pocket will be assessed using Bravo capsules. The unit of measure is in pH.
Measured: 48 hours
Frequency of night-time reflux
Frequency of night-time reflux will be assessed using pH-impedance studies.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study startJul 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Asymptomatic obese patients will be randomised into either groups according to alginate antacid group \[Gaviscon Advance (GA), Reckitt Benckiser, UK\] and non antacid alginate group \[simple antacid\]. Both groups will be studied for 48 hours using the ambulatory wireless capsule and pH impedance. Participants according to their group will take either alginate antcid \[Gaviscon Advance (GA), Reckitt Benckiser, UK\] or non alginate antacid \[simple antacid\] which has equivalent strength of antacid after taking late night standardised meals.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeong Yeh Lee, Universiti Sains Malaysia
- Investigators
- Yeong Yeh Lee, MD, PhD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516188
- Sponsor's protocol ID
- 15020071
- Status last verified
- May 2018
- First submitted
- 18 Oct 2017
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deraman MA, Abdul Hafidz MI, Lawenko RM, Ma ZF, Wong MS, Coyle C, Lee YY. Randomised clinical trial: the effectiveness of Gaviscon Advance vs non-alginate antacid in suppression of acid pocket and post-prandial reflux in obese individuals after late-night supper. Aliment Pharmacol Ther. 2020 Jun;51(11):1014-1021. doi: 10.1111/apt.15746. Epub 2020 Apr 28.
PubMed 32343001
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Antacid-controlled Randomized Study on Effectiveness of Alginate-antacid Preparation (Gaviscon-Advance®) in Suppression of Post-supper Acid-pocket, Night-time Acid-reflux and Symptoms in Obese Participants
- ClinicalTrials.gov ID
- NCT03516188
- Acronym / sponsor ID
- 15020071
- Conditions
- Gastroesophageal Reflux Disease, Acid Reflux, Obesity
- Keywords
- Gastroesophageal Reflux Disease, Acid pocket, Acid Reflux, Alginate antacid, Obesity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 4 May 2018 (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 randomized, open-label study with antacid-control will be performed over 48 hours period by continuous pH impedance and bravo capsule monitoring. Asymptomatic obese patients will be separated into either groups according to alginate antacid group [Gaviscon Advance (GA)®, Reckitt Benckiser, UK] and non antacid alginate group [simple antacid]. Both groups will be studied for 48 hours using the ambulatory wireless capsule and pH impedance. Participants according to their group will take either alginate antcid [Gaviscon Advance (GA)®, Reckitt Benckiser, UK] or non alginate antacid [simple antacid] which has equivalent strength of antacid after taking late night standardised meals.
Detailed description
Gastroesophageal reflux disease (GERD) with symptoms of heartburn and acid regurgitation is a common disorder especially in overweight and obese persons who are at increased risk for GERD. Late night supper, an usual eating habit in many parts of the world, may worsen GERD and especially so among the obese, and this may be due to increased reflux from acid pocket.
Acid pocket in the proximal part of stomach after meals has been shown to be an important mechanism of GERD. The acid pocket is increasingly recognized as a source from which acid reflux events originate. To what extent changes in acidity of the acid pocket contribute to the therapeutic effect of alginate antacid formulation is inconsistent. The other findings suggested that the main mechanism of action for the alginate-antacid combination is to displace the post-prandial acid pocket rather than mechanically containing it.
Therefore, the outcomes of the study will allow us to determine whether late night supper worsen acid pocket, night time reflux and symptoms and whether an alginate antacid preparation (Gaviscon Advance®) is useful in suppression of acid pocket, night time refluxes and symptom (s). A benefit is that this study may inform doctors and advise participants of GERD side-effects of late night supper and how Gaviscon Advance may help.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Asymptomatic obese patients will be randomised into either groups according to alginate antacid group [Gaviscon Advance (GA), Reckitt Benckiser, UK] and non antacid alginate group [simple antacid]. Both groups will be studied for 48 hours using the ambulatory wireless capsule and pH impedance. Participants according to their group will take either alginate antcid [Gaviscon Advance (GA), Reckitt Benckiser, UK] or non alginate antacid [simple antacid] which has equivalent strength of antacid after taking late night standardised meals.
| Arm | Type | Receives |
|---|---|---|
| Alginate-antacid group | Experimental | Drug: Alginate-antacid groupParticipants will take normal meals with late night supper (i.e.two chicken burgers and one cup or 250 ml of teh-tarik) plus alginate-antacid. |
| Non antacid alginate group | Experimental | Drug: Non antacid alginate groupParticipants will take normal meals with late night supper (i.e.two chicken burgers and one cup or 250 ml of teh-tarik) plus antacid alone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged greater than or equal to 18 years and less than or equal to 70 years.
- BMI >27.5 (based on kg/m2)
- 4. Not taking acid suppressant PPI and H2 receptor blockers 5. Not taking antacids or alginate preparations, except those administered as part of study procedure.
Key exclusion criteria (5 listed)
- Those with gastrointestinal symptoms indicative of GERD, gastric carcinoma, previous or current peptic ulcer disease.
- Those with a history of upper GI surgery prior to this.
- Those with haematological disorders, bleeding tendency, recurrent nose bleeds or treatment with anti-coagulants).
- Those who had any previous history of allergy or known intolerance to any of the study drugs or the following formulation constituents: Gaviscon® liquid: sodium alginate, sodium bicarbonate and calcium carbonate
- Those with physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures.
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 |
|---|---|---|
| Alginate-antacid groupAlso: Gaviscon-Advance®Participants will be given 10 mL of alginate-antacid preparation (Gaviscon-Advance®, Reckitt-Benckiser, United Kingdom) | Drug | Alginate-antacid group |
| Non antacid alginate groupAlso: Magnesium tri-silicateParticipants will be given 4 mL of magnesium tri-silicate which has equivalent strength and component with Gaviscon-Advance® except it is alginate-free. | Drug | Non antacid alginate group |
Primary outcome
Duration of acid-pocket
Time frame: 48 hours
Duration of acid-pocket will be assessed using Bravo capsules. The unit of measure is in minutes.
3 secondary outcomes
Symptom response
Time frame: 48 hours
Acidity of acid-pocket
Time frame: 48 hours
Frequency of night-time reflux
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Derived from this study: PubMed 32343001Deraman MA, Abdul Hafidz MI, Lawenko RM, Ma ZF, Wong MS, Coyle C, Lee YY. Randomised clinical trial: the effectiveness of Gaviscon Advance vs non-alginate antacid in suppression of acid pocket and post-prandial reflux in obese individuals after late-night supper. Aliment Pharmacol Ther. 2020 Jun;51(11):1014-1021. doi: 10.1111/apt.15746. Epub 2020 Apr 28.
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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.
Yeong Yeh Lee, MD, PhD principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Alginate-antacid group and Non antacid alginate group in people with Gastroesophageal Reflux Disease and Acid Reflux, run by Universiti Sains Malaysia at 1 site in Malaysia.
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 3 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: finished, as of the sponsor's last update on 4 May 2018. 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 Malaysia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of acid-pocket (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03516188, which also lists 1 linked publication.
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 4 May 2018.