Obesity Clinical Trial
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
Verified date | May 2018 |
Source | University of Science Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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: GavisconĀ® 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. |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospitial Universiti Sains Malaysia | Kubang Kerian | Kelantan |
Lead Sponsor | Collaborator |
---|---|
University of Science Malaysia |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of acid-pocket | Duration of acid-pocket will be assessed using Bravo capsules. The unit of measure is in minutes. | 48 hours | |
Secondary | Symptom response | Symptom response will be assessed using visual analogue scale (0 - 10). | 48 hours | |
Secondary | Acidity of acid-pocket | Acidity of acid-pocket will be assessed using Bravo capsules. The unit of measure is in pH. | 48 hours | |
Secondary | Frequency of night-time reflux | Frequency of night-time reflux will be assessed using pH-impedance studies. | 48 hours |
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