Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00139776
Recruitment Status : Completed
First Posted : August 31, 2005
Results First Posted : May 19, 2009
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Osteoarthritis, Hip Drug: Celecoxib Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 875 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Celecoxib

Arm Intervention/treatment
Active Comparator: Celecoxib - Continuous use Drug: Celecoxib

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.


Active Comparator: Celecoxib - Intermittent use Drug: Celecoxib

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.





Primary Outcome Measures :
  1. Number of Flare Events Per Time of Exposure to Study Medication [ Time Frame: 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 :
  1. Time to Occurrence of First Osteoarthritis (OA) Flare [ Time Frame: 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

  2. Proportion of Days Free From Osteoarthritis (OA) Flare [ Time Frame: 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.

  3. Proportion of Days in Osteoarthritis (OA) Flare [ Time Frame: 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.

  4. Arthritis Pain Numerical Rating Scale (NRS) [ Time Frame: 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.

  5. Patient's Global Assessment of Arthritis [ Time Frame: 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.

  6. Physician's Global Assessment of Arthritis at Final Visit [ Time Frame: Period III (22 weeks) ]
    Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor).

  7. Total Rescue Medication Taken (Mean) [ Time Frame: Period III (22 weeks) ]
    Total amount of rescue medication (acetaminophen in milligrams [mg]) taken per month per participant

  8. Proportion of Days on Rescue Medication [ Time Frame: Period III (22 weeks) ]
    Days on rescue medication divided by number of days on study medication in Period III

  9. Days on Flare Medication [ Time Frame: 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

  10. Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Time Frame: 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.

  11. Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Time Frame: 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.


Other Outcome Measures:
  1. Change in Medical Outcomes Study Sleep Scale - All Assessments [ Time Frame: Period III ]
    Subject assessment on 7 sleep associated categories. Raw scores are transformed to a 0-100 scale. Higher score indicates more of the outcome (e.g. more snoring, more adequate sleep). Score at end of Period III minus score at start of Period III.

  2. Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep [ Time Frame: Period III ]
    Transformed score scale: 1=optimal; 0=not optimal; mixed = both optimal and non-optimal sleep during Period III

  3. Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments [ Time Frame: Period III ]
    SF-12v2 is a 12 item health survey covering 7 topics. Raw scores are transformed to a 0 to 100 scale. Higher scores indicate better state of health. Score at end of Period III minus score at start of Period III.

  4. Serious Adverse Events in Open Label run-in Period [ Time Frame: 2 weeks prior to double blind dosing ]
    Serious adverse events occuring during the 2 week run-in period (Period II) when all participants were dosed with celecoxib 200 mg daily



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139776


Locations
Show Show 124 study locations
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00139776    
Other Study ID Numbers: A3191173
First Posted: August 31, 2005    Key Record Dates
Results First Posted: May 19, 2009
Last Update Posted: March 29, 2021
Last Verified: March 2021
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action