| August 29, 2005 |
| June 24, 2009 |
| July 2005 |
| February 2008 (final data collection date for primary outcome measure) |
| Number of Flare Events Per Time of Exposure to Study Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ] |
| To determine whether continuous use over a 6-month period of celecoxib 200 mg per day is more effective than intermittent use of celecoxib 200 mg per day in preventing spontaneous osteoarthritis flares. |
| Complete list of historical versions of study NCT00139776 on ClinicalTrials.gov Archive Site |
- Time to Occurrence of First Osteoarthritis (OA) Flare [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
- Proportion of Days Free From Osteoarthritis (OA) Flare [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
- Proportion of Days in Osteoarthritis (OA) Flare [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
- Arthritis Pain Numerical Rating Scale (NRS) [ Time Frame: Period III ] [ Designated as safety issue: No ]
- Patient's Global Assessment of Arthritis [ Time Frame: Period III ] [ Designated as safety issue: No ]
- Physician's Global Assessment of Arthritis at Final Visit [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
- Total Rescue Medication Taken (Mean) [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
- Proportion of Days on Rescue Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
- Days on Flare Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
- Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
- Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
|
| To evaluate the safety and tolerability of continuous use over a 6-month period of celecoxib 200 mg QD versus "usual use" celecoxib 200mg QD. To assess whether disease management |
| |
| Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use" |
| 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 |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
- Osteoarthritis, Knee
- Osteoarthritis, Hip
|
| Drug: Celecoxib |
| |
| |
| |
| Completed |
| 875 |
| February 2008 |
| February 2008 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Belgium, Brazil, Canada, Chile, Colombia, France, United Kingdom |
| |
| NCT00139776 |
| Director, Clinical Trial Disclosure Group, Pfizer |
| A3191173 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| June 2009 |
