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

January 18, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: DIAGNOSTIC
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pH over 24hours Time Frame: over 24hours	over 24hours

Secondary Outcome Measures

Outcome Measure	Time Frame
%24 hours pH>4 Median gastric pH Adverse events Time Frame: over 24 hours	over 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

November 27, 2006

First Submitted That Met QC Criteria