Last updated: 11/04/2018 08:44:52

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

GSK study ID
LAV104616
Clinicaltrials.gov ID
NCT00405119
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

pH over 24hours

Timeframe: over 24hours

Secondary outcomes:

%24 hours pH>4 Median gastric pH Adverse events

Timeframe: over 24 hours

Interventions:
  • Drug: AH23844 (lavoltidine)
  • Drug: NEXIUM (esomeprazole)
  • Drug: ZANTAC (ranitidine)
    • Enrollment:
    92
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Gastroesophageal reflux disease
    Product
    lavoltidine
    Collaborators
    Not applicable
    Study date(s)
    May 2006 to March 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Subject must have a Body Mass Index (BMI) from 19-30 kg/m2
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Randwick, New South Wales, Australia, 2031
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Herston, Queensland, Australia, 4006
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-15-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website