A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease
Intervention: AH23844 (lavoltidine) (Drug); NEXIUM (esomeprazole) (Drug); ZANTAC (ranitidine) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, BSc(Hons) MB BS PhD FRACP, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: 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
Study design: Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: pH over 24hours
Secondary outcome: %24 hours pH>4
Median gastric pH
Adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
GSK Clinical Trials Call Center, Randwick, New South Wales 2031, Australia
Additional Information
Starting date: April 2006
Last updated: June 21, 2007
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