Status:
COMPLETED
A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Gastroesophageal Reflux Disease
Reflux, Gastroesophageal
Eligibility:
MALE
18-55 years
Phase:
PHASE2
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 da...
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 f...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subject must have a Body Mass Index (BMI) from 19-30 kg/m2
- Subject does not present with abnormal clinical lab findings
- Subject is able to tolerate a nasogastric pH electrode.
- Exclusion criteria:
- Subject is Helicobacter-positive on a C13 urea breath test
- Subject has a baseline median 24-hour gastric pH\>3
- For Part B of the study, subjects are CYP 2C19 poor metabolizers.
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00405119
Start Date
May 1 2006
End Date
March 1 2007
Last Update
January 19 2017
Active Locations (2)
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1
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
2
GSK Investigational Site
Herston, Queensland, Australia, 4006