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Gaviscon Advance added to once-daily PPI therapy in adults with inadequately controlled gastroesophageal reflux disease
2011-005486-21Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2012
- Countries
- 1
- Sponsor
- Reckitt
- Modality
- Small Molecules
- Drugs
- gaviscon advance
- Conditions
- gastroesophageal reflux disease (GERD)
01
Overview
Phase 3, randomised, double-blind trial in gastroesophageal reflux disease (GERD) comparing Gaviscon Advance add-on with Placebo add-on (2 arms). Primary endpoint: Change in HRDQ heartburn and regurgitation scores. Started Jan 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Gaviscon Advance add-on
Participants continue once-daily proton pump inhibitor therapy and receive Gaviscon Advance aniseed flavoured oral suspension as add-on treatment for 7 days.
Placebo add-on
Participants continue once-daily proton pump inhibitor therapy and receive matching placebo oral suspension as add-on treatment for 7 days.
03
Who it enrols
Adult men and women (≥18 years) with gastroesophageal reflux disease whose symptoms are inadequately controlled by once daily proton pump inhibitor therapy, excluding those with significant structural or severe erosive esophageal disease such as oesophageal stricture, peptic ulcer disease, Zollinger-Ellison syndrome, systemic sclerosis, or recent endoscopy showing LA grade C or D oesophagitis.
04
Endpoints
Primary
Change in HRDQ heartburn and regurgitation scores
Secondary
Change in HRDQ dyspepsia scores
Quality of life
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