Last updated: 11/04/2018 08:45:00

Open-label comparison of 24hr gastric pH on Days 1, 2, 7 with once-daily administration of lavoltidine 40 mg.

GSK study ID
LAV110285
Clinicaltrials.gov ID
NCT00551473
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: An Open-Label study of the Development of Pharmacodynamic Tolerance to 7-days Administration of Lavoltidine 40mg
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 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.
Primary purpose:
Diagnostic
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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.

Timeframe: seven days

Secondary outcomes:

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.

Timeframe: seven days

Interventions:
  • Drug: Lavoltidine
    • Enrollment:
    18
    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 2007 to June 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Healthy male, from 18-55 years
    • Have BMI from 19-30 kg/m2
    • Helicobacter-positive on a C13 urea breath test
    • have a baseline median 24-hour gastric pH>3
    Inclusion and exclusion criteria
    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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Randwick, Sydney, New South Wales, Australia, 2031
    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
    2007-28-06

    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
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