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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00405119

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: AH23844 (lavoltidine) Drug: NEXIUM (esomeprazole) Drug: ZANTAC (ranitidine)	Phase II

MedlinePlus related topics: GERD

Drug Information available for: Ranitidine Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Ranitidine Hydrochloride Ranitidine bismuth citrate Lavoltidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

pH over 24hours [ Time Frame: over 24hours ]

Secondary Outcome Measures:

%24 hours pH>4 Median gastric pH Adverse events [ Time Frame: over 24 hours ]

Enrollment:	92
Study Start Date:	May 2006

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405119

Locations

Australia, New South Wales
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Australia, Queensland
GSK Investigational Site
Herston, Queensland, Australia, 4006

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	LAV104616
Study First Received:	November 27, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00405119
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

AH23844
gastroesophageal reflux disease (GERD)
pharmacokinetics
pharmacodynamics

tolerance
ranitidine
esomeprazole

Study placed in the following topic categories:

Bismuth tripotassium dicitrate
Esophageal disorder
Gastrointestinal Diseases
Citric Acid
Omeprazole
Gastroesophageal Reflux
Histamine
Bismuth

Esophageal Motility Disorders
Deglutition Disorders
Ranitidine
Digestive System Diseases
Ranitidine bismuth citrate
Histamine phosphate
Esophageal Diseases
Loxtidine

Additional relevant MeSH terms:

Neurotransmitter Agents
Histamine Antagonists
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Anti-Ulcer Agents

Gastrointestinal Agents
Histamine Agents
Enzyme Inhibitors
Histamine H2 Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009