Efficacy of Gaviscon-Advance® in Suppressing Post-supper Acid-pocket and Night-time Acid-reflux in Obese Participants

May 3, 2018 updated by: Yeong Yeh Lee, Universiti Sains Malaysia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Hospitial Universiti Sains Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged greater than or equal to 18 years and less than or equal to 70 years.
  2. 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.

Exclusion Criteria:

  1. Those with gastrointestinal symptoms indicative of GERD, gastric carcinoma, previous or current peptic ulcer disease.
  2. Those with a history of upper GI surgery prior to this.
  3. Those with haematological disorders, bleeding tendency, recurrent nose bleeds or treatment with anti-coagulants).
  4. 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
  5. Those with physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alginate-antacid group
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.
Drug: Alginate-antacid group
Participants will be given 10 mL of alginate-antacid preparation (Gaviscon-Advance®, Reckitt-Benckiser, United Kingdom)
Other Names:
  • Gaviscon-Advance®
Experimental: Non antacid alginate group
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.
Drug: Non antacid alginate group
Participants will be given 4 mL of magnesium tri-silicate which has equivalent strength and component with Gaviscon-Advance® except it is alginate-free.
Other Names:
  • Magnesium tri-silicate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom response
Time Frame: 48 hours
Symptom response will be assessed using visual analogue scale (0 - 10).
48 hours
Acidity of acid-pocket
Time Frame: 48 hours
Acidity of acid-pocket will be assessed using Bravo capsules. The unit of measure is in pH.
48 hours
Frequency of night-time reflux
Time Frame: 48 hours
Frequency of night-time reflux will be assessed using pH-impedance studies.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Investigators

  • Principal Investigator: Yeong Yeh Lee, MD, PhD, Universiti Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

May 3, 2018

First Posted (Actual)

May 4, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15020071

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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