Clinical Trials Directory

Trials / Completed

CompletedNCT00405119

A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
92 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
Male
Age
18 Years – 55 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
DRUGAH23844 (lavoltidine)
DRUGNEXIUM (esomeprazole)
DRUGZANTAC (ranitidine)

Timeline

Start date
2006-05-01
Primary completion
2007-03-01
Completion
2007-03-01
First posted
2006-11-29
Last updated
2017-01-19

Locations

2 sites across 1 country: Australia

Source: ClinicalTrials.gov record NCT00405119. Inclusion in this directory is not an endorsement.