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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
- Subjects diagnosed with primary Osteoarthritis of the knee.
- Have at least 3 months in symptom duration prior to screening visit.
- History of hypersensitivity to NSAIDS.
- Allergy to Ibuprofen.
Inclusion and exclusion 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
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031
Status
Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
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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