Osteoarthritis
Conditions
Keywords
Osteoarthritis, Ibuprofen, COX2, VAS, knee, single dose
Brief summary
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.
Interventions
DRUGIbuprofen
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity recorded over 0-8 hours using question 1 of the WOMAC (Western Ontario and McMaster University Osteoarthritis Index)pain subscale (visual analog scale). | — |
Secondary
| Measure | Time frame |
|---|---|
| Responder rate Patient impression of change - 8 & 24 hrs post dose Time to use of rescue medication (paracetamol) | — |
Countries
Australia
Outcome results
None listed