Last updated: 11/04/2018 05:52:33

Dose Response and Efficacy of GW842166 in Pain

GSK study ID
CBA110877
Clinicaltrials.gov ID
NCT00554762
EudraCT ID
2007-003308-37
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A phase I, placebo controlled, randomised, double blind two-way crossover study to investigate the dose response and efficacy of single and repeat doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments.
Trial description: The purpose of this study is to assess the dose response and efficacy of single and repeat doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

• Heat pain threshold at 5 hours post dose

Timeframe: 5 Hours

Secondary outcomes:

• Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose.

Timeframe: 5 Hours

Interventions:
  • Drug: GW842166X
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects
    Product
    GW842166
    Collaborators
    Not applicable
    Study date(s)
    January 2008 to March 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 years
    Accepts healthy volunteers
    Yes
    • Healthy male or female subjects aged 18 to 50 years inclusive
    • Body Weight >50 Kg and BMI within the range 18.5 to 32 kg/m2 inclusive.
    • The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test.
    • A positive pre-study (HIV), hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of the start of the study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male or female subjects aged 18 to 50 years inclusive
    • Body Weight >50 Kg and BMI within the range 18.5 to 32 kg/m2 inclusive.
    • Women who are not of child bearing potential
    Exclusion criteria:
    • The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test.
    • A positive pre-study (HIV), hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of the start of the study.
    • Abuse of alcohol defined as an average weekly intake of greater than 28 units (21 units for women) or an average daily intake of greater than 3 units (2 units for women). 1 unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
    • Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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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