Study Of Continuous Use Of Celecoxib Vs. Usual or Intermittent Use

Study Overview
=================
Brief Summary
-----------------
To determine whether continuous use of celecoxib over a 6-month period is more efficacious than usual or intermittent use in preventing spontaneous osteoarthritis flares of the knee and hip.

Official Title
-----------------
Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of Continuous Use Of Celecoxib Vs. The Usual Use Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-inflammatory Medication for Control Of Their Pain

Conditions
-----------------
Osteoarthritis, Knee, Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Drug: Celecoxib
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone telephone. Exclusion Criteria: Subject has had surgery on index joint. Subject has history of rheumatoid arthritis or fibromyalgia syndrome. Subject has active gastrointestinal or cardiovascular disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Celecoxib - Continuous use<br> | Drug: Celecoxib<br>* 24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily. Placebo used as flare medication when directed.<br>|
| Active Comparator: Celecoxib - Intermittent use<br> | Drug: Celecoxib<br>* 24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Flare Events Per Time of Exposure to Study Medication | Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system. | Period III (22 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Occurrence of First Osteoarthritis (OA) Flare | Time from first dose of double blind medication (start of Period III) to occurrence of first OA flare. Flare was determined using pre-defined criteria, using an interactive voice response system | Period III (22 weeks) | 
| Proportion of Days Free From Osteoarthritis (OA) Flare | Number of days subject was free from OA flare divided by number of days on study medication in Period III. Flare was determined using pre-defined criteria, using an interactive voice response system. | Period III (22 weeks) | 
| Proportion of Days in Osteoarthritis (OA) Flare | Number of days subject was in OA flare divided by number of days on study medication in Period III. Subjects may have more than one flare. Flare was determined using pre-defined criteria, using an interactive voice response system. | Period III (22 weeks) | 
| Arthritis Pain Numerical Rating Scale (NRS) | Participant rated intensity of osteoarthritis pain on categorical scale from 0 (no pain) to 10 (worst pain). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III. | Period III | 
| Patient's Global Assessment of Arthritis | Participant's response to question Considering all the ways the osteoarthritis in your hip or knee affects you, how are you doing today? on scale from 1 (very good) to 5 (very poor). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III. | Period III | 
| Physician's Global Assessment of Arthritis at Final Visit | Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor). | Period III (22 weeks) | 
| Total Rescue Medication Taken (Mean) | Total amount of rescue medication (acetaminophen in milligrams [mg]) taken per month per participant | Period III (22 weeks) | 
| Proportion of Days on Rescue Medication | Days on rescue medication divided by number of days on study medication in Period III | Period III (22 weeks) | 
| Days on Flare Medication | Number of days on flare medication per month per subject calculated as number of days on flare medication divided by the number of days on study medication in Period III | Period III (22 weeks) | 
| Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores | Score at end of Period III minus score at start of Period III. WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Negative change indicates improvement. | Period III (22 weeks) | 
| Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores | WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Scores analyzed as area under the curve (AUC) of participant's WOMAC scores from each assessment in Period III. | Period III (22 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use