This is an observation of the current use of a transdermal preparation of Celecoxib 8% which is being used in the treatment of patients with primary OA of the knees. Subjects will be followed for 12 weeks.
This is an observation of the current use of a transdermal preparation of Celecoxib 8% which is being used in the treatment of patients with primary OA of the knees. This transdermal celecoxib preparation is currently in use in multiple rheumatology clinics in southern Ontario, Canada. Only patients that have been prescribed the celecoxib cream will be approached for screening and subsequent study participation. The study is purely observational as the protocol does not dictate treatment or dose assignment. Subjects will be followed for 12 weeks. In addition to the baseline clinic visit, they will participate in 2 telephone calls where data will be collected on outcome assessments that measure disease severity. The data collected during those visits will be compared to baseline values of the same assessments.
Study Type
OBSERVATIONAL
Enrollment
6
transdermal delivery of 8% Celecoxib
Dr. Angela Montgomery - Rheumatologist
Mississauga, Ontario, Canada
Dr. Brandusa Florica - Rheumatologist
Mississauga, Ontario, Canada
Credit Valley Rheumatology
Mississauga, Ontario, Canada
Can study personnel enrol at least 70% of all eligible patients.
The screening log will be reviewed to determine how many eligible participants consented to study participation. The evaluation may also include reasons for ineligibility. This objective will be met if the threshold of least 70% is met.
Time frame: This data will be collected during recruitment. Recruitment will end when the enrolment target of 45 subjects has been met.
Can study personnel collect 100% of the data scheduled to be collected from at least 70% of the enrolled subjects.
This objective will be met if 100% of study assessments (Western Ontario and McMaster University (WOMAC) Osteoarthritis index scores, Numeric Rating Score (NRS) Pain Index and Patient Global Assessment (PGA) score) is collected from ≥ 70% of the enrolled patients.
Time frame: Baseline data will be compared to data collected after 12-weeks of treatment.
Calculate the Sample standard deviation of Western Ontario and McMaster University (WOMAC) Osteoarthritis index scores from this population.
Higher WOMAC scores indicate an increase in disease severity, i.e.: increased pain and decrease functionality. The mean and standard deviation of the sample will be calculated from the observations collected for WOMAC assessment. It will be used for future sample size calculations.
Time frame: Baseline data will be compared to data collected after 12-weeks of treatment.
Calculate Sample standard deviations of Patient Global Assessment (PGA) scores from this population.
The standard deviations will be calculated from the observations collected for PGA. It will be used for future sample size calculations. Higher scores reflect greater disease severity from the patient's perspective. Scores range from 0- "No symptoms" to 10 "Worst symptoms imaginable"
Time frame: Baseline data will be compared to data collected after 12-weeks of treatment.
Calculate Sample standard deviations of Numeric Rating Score (NRS) Pain Index from this population.
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The standard deviations will be calculated from the observations collected for NRS assessment. It will be used for future sample size calculations. Higher pain scores indicate grater pain experienced by the subject. Scores range from 0- "No pain" to 10 "Worst pain imaginable"
Time frame: Baseline data will be compared to data collected after 12-weeks of treatment.