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

NCT03516188 | Completed Phase 2 DMC

• 1 other identifier: 15020071
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Gastroesophageal Reflux Disease; Acid Reflux; Obesity

Keywords

Gastroesophageal Reflux Disease; Acid pocket; Acid Reflux; Alginate antacid; Obesity

Outcome Measures

Primary Outcomes (1)

• Duration of acid-pocket

  Duration of acid-pocket will be assessed using Bravo capsules. The unit of measure is in minutes.

  48 hours

Secondary Outcomes (3)

• Symptom response

  48 hours

• Acidity of acid-pocket

  48 hours

• Frequency of night-time reflux

  48 hours

Study Arms (2)

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.

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.

Drug: Non antacid alginate group

Interventions

Alginate-antacid group DRUG

Participants will be given 10 mL of alginate-antacid preparation (Gaviscon-Advance®, Reckitt-Benckiser, United Kingdom)

Also known as: Gaviscon-Advance®

Alginate-antacid group

Non antacid alginate group DRUG

Participants will be given 4 mL of magnesium tri-silicate which has equivalent strength and component with Gaviscon-Advance® except it is alginate-free.

Also known as: Magnesium tri-silicate

Non antacid alginate group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged greater than or equal to 18 years and less than or equal to 70 years.
• BMI \>27.5 (based on kg/m2)
• \. Not taking acid suppressant PPI and H2 receptor blockers 5. Not taking antacids or alginate preparations, except those administered as part of study procedure.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospitial Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 32343001 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Obesity

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yeong Yeh Lee, MD, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: May 4, 2018
• Study Start: July 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

MY (1)