Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"
- Registration Number
- NCT00139776
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 875
- 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.
- Subject has had surgery on index joint.
- Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
- Subject has active gastrointestinal or cardiovascular disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Celecoxib - Continuous use Celecoxib - Celecoxib - Intermittent use Celecoxib -
- Primary Outcome Measures
Name Time Method Number of Flare Events Per Time of Exposure to Study Medication Period III (22 weeks) 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.
- Secondary Outcome Measures
Name Time Method Physician's Global Assessment of Arthritis at Final Visit Period III (22 weeks) Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor).
Total Rescue Medication Taken (Mean) Period III (22 weeks) Total amount of rescue medication (acetaminophen in milligrams \[mg\]) taken per month per participant
Days on Flare Medication Period III (22 weeks) 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
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores Period III (22 weeks) 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.
Time to Occurrence of First Osteoarthritis (OA) Flare Period III (22 weeks) 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
Proportion of Days Free From Osteoarthritis (OA) Flare Period III (22 weeks) 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.
Patient's Global Assessment of Arthritis Period III 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.
Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores Period III (22 weeks) 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.
Proportion of Days in Osteoarthritis (OA) Flare Period III (22 weeks) 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.
Arthritis Pain Numerical Rating Scale (NRS) Period III 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.
Proportion of Days on Rescue Medication Period III (22 weeks) Days on rescue medication divided by number of days on study medication in Period III
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Trowbridge, United Kingdom