A Randomized, Double-blind, Four Period Cross-over Comparison of the Effect of Two Doses Lavoltidine, Esomeprazole, and Placebo on 24 Hour Gastric pH and Frequency of Heartburn in Symptomatic GERD Subjects Without Esophageal Erosions
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Gastroesophageal Reflux Disease
- Sponsor
- GlaxoSmithKline
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- pH over 24hours
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Current treatment for gastroesophageal reflux disease (GERD) confirms an unmet need in patients, based on slow onset of action and an inability to provide 24-hour gastric-acid suppression. Clinical data on AH234844 demonstrates a rapid onset of action, high potency, and prolonged duration of effect. The present study endeavors, in part, to compare lavoltidine to two GERD drugs, NEXIUM and ranitidine.
Detailed Description
A three-part study in healthy male volunteers to determine the most effective of four different lavoltidine doses on gastric pH and to compare the most effective dose with NEXIUM (esomeprazole) 40mg for the inhibition of gastric-acid secretion and with ranitidine (300mg/day) for the amount of pharmacodynamic tolerance
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
pH over 24hours
Time Frame: over 24hours
Secondary Outcomes
- %24 hours pH>4 Median gastric pH Adverse events(over 24 hours)