Open-label Comparison of 24hr Gastric pH on Days 1, 2, 7 With Once-daily Administration of Lavoltidine 40 mg.

May 31, 2012 updated by: GlaxoSmithKline

An Open-Label Study of the Development of Pharmacodynamic Tolerance to 7-days Administration of Lavoltidine 40mg

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 lavoltidine demonstrates a rapid onset of action, high potency, and prolonged duration of effect after single dose. Since tolerance to the class of compounds to which lavoltidine belongs may be dose dependent, the current study is designed to determine if 40mg lavoltdine given for 7days develops tolerance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

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, Sydney, New South Wales, Australia, 2031
        • 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:

  • Healthy male, from 18-55 years
  • Have BMI from 19-30 kg/m2
  • do not present with abnormal clinical lab findings
  • are able to tolerate a nasogastric pH electrode.

Exclusion Criteria:

  • Helicobacter-positive on a C13 urea breath test
  • have a baseline median 24-hour gastric pH>3

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the degree of pharmacodynamic tolerance following seven days administration of lavoltidine 40mg on gastric pH as assessed by percentage of 24hrs pH>4.
Time Frame: seven days
seven days

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine whether or not significant pharmacodynamic tolerance occurs as early as the second dose of 40mg lavoltidine. Safety and tolerance of seven days administration of lavoltidine 40 mg, in healthy male volunteers.
Time Frame: seven days
seven days

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, 2007

Study Registration Dates

First Submitted

October 29, 2007

First Submitted That Met QC Criteria

October 29, 2007

First Posted (Estimate)

October 31, 2007

Study Record Updates

Last Update Posted (Estimate)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAV110285

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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