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

NCT03516188 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-05-04

No results posted yet for this study

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

Interventions

DRUG

Alginate-antacid group

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

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.

Sponsors & Collaborators

  • Universiti Sains Malaysia

    lead OTHER

Principal Investigators

  • Yeong Yeh Lee, MD, PhD · Universiti Sains Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516188 on ClinicalTrials.gov