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

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universiti Sains Malaysia; University of Science Malaysia
• Treatments: Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination; Alginic acid; Almagate; Aluminum Hydroxide; Antacids; Anti-Ulcer Agents; Magnesium Hydroxide

Criteria

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.