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

Phase 2

Completed

• Conditions: Gastroesophageal Reflux Disease; Reflux, Gastroesophageal

• Registration Number: NCT00405119
• Lead Sponsor: GlaxoSmithKline

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

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-11-27
• Study First Submitted QC: 2006-11-27
• Study First Posted: 2006-11-29
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 92

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
pH over 24hours	over 24hours

Secondary Outcome Measures

Name	Time	Method
%24 hours pH>4 Median gastric pH Adverse events	over 24 hours

Trial Locations

Locations (1)

GSK Investigational Site; 🇦🇺 Herston, Queensland, Australia