Osteoarthritis, Knee
Conditions
Brief summary
The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill.
Interventions
DRUGibuprofen
Patients will receive 800 mg ibuprofen in one of the three treatment periods.
DRUGPlacebo
Patients will receive placebo to ibuprofen in two of the three treatment periods.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The primary source of pain is the study knee of one lower extremity * Patient is willing to limit alcohol and caffeine intake * Aside from osteoarthritis, patient is in generally good health * Patient is capable of completing protocol specified walks * Patient is able to understand and complete questionnaires in English * Patient has previously benefited from the use of either NSAIDs, COX-2 inhibitors, or acetaminophen
Exclusion criteria
* Patient has another condition which could interfere with evaluating pain in the knee being tested * Patient is not able to take a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen * Patient has a history or current evidence of stroke, transient ischemic attack, liver disease or cancer * Patient has a history or current evidence of dizziness, unsteadiness, or falling * Patient has congestive heart failure, unstable angina or uncontrolled high blood pressure * Patient has a history of stomach, digestive track, or small intestine surgery * Patient is unable to complete the study questionnaires in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks | All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval) | Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk. Change from baseline was average of post-dose PIs minus average of pre-dose PI. |
Participant flow
Recruitment details
First Patient Entered 16 Mar 2007 Multicenter, 3 sites
Pre-assignment details
This study is a single dose, multi-center, randomized, placebo controlled, cross-over study using the Walking Model of Osteoarthritis (OA) knee pain. The efficacy and tolerability of a single dose of Ibuprofen 800 mg in the setting of standardized walks will be compared with placebo.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 60.78 years |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 11 | 3 / 11 | 3 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 1 / 11 |
Outcome results
Primary
Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks
Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk. Change from baseline was average of post-dose PIs minus average of pre-dose PI.
Time frame: All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)
Population: This is a crossover study. Total number of participants was 33; every participant had one ibuprofen period and two placebo periods.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen | Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks | 0.24 Units on a Scale | Standard Deviation 0.77 |
| Placebo 1 | Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks | 0.18 Units on a Scale | Standard Deviation 0.77 |
| Placebo 2 | Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks | 0.18 Units on a Scale | Standard Deviation 0.77 |
Comparison: Primary efficacy endpoint was assessed by an ANOVA model with terms for treatment, period, sequence, and patients within sequence. Efficacy advantage over placebo was assessed via the treatment difference in the least-squares (LS) means (ibuprofen vs. average of the 2 placebo treatments) from the ANOVA model and the 90% confidence interval (CI; one-sided alpha=0.05) of the LS mean difference will be assessed.p-value: 0.74390% CI: [-0.23, 0.35]ANOVA