Last updated: 11/04/2018 05:59:01

Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee

GSK study ID
COX103843
Clinicaltrials.gov ID
NCT00372801
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 Double-Blind, Randomised, Placebo-controlled, cross-over pilot study to investigate the efficacy of Ibuprofen in patients with Osteoarthritis of the knee following administration of a single dose
Trial description: To demonstrate that new drugs work, many complex multidose studies are often required. The intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to validate a simpler single dose model for future assessment of new pain drugs.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Ibuprofen
    • Enrollment:
    36
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Osteoarthritis
    Product
    GW644784
    Collaborators
    Not applicable
    Study date(s)
    August 2005 to March 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable N/A - 80 Years
    Accepts healthy volunteers
    no
    • Inclusion criteria:
    • Subjects diagnosed with primary Osteoarthritis of the knee.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Subjects diagnosed with primary Osteoarthritis of the knee.
    • Have at least 3 months in symptom duration prior to screening visit.
    • Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective cyclo-oxygenase II (COX2) inhibitor for management of knee pain.
    • Pain walking on flat surface within specific interval prior to study start. Exclusion criteria:
    • History of hypersensitivity to NSAIDS.
    • Allergy to Ibuprofen.
    • Use of assistive devices other than a cane or knee brace.
    • History of specified diseases/illnesses.
    • Abnormal blood tests pre-study.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Randwick, Sydney, New South Wales, Australia, 2031
    Status
    Recruiting
    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
    2007-20-03

    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
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