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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139776
First received: August 29, 2005
Last updated: June 24, 2009
Last verified: June 2009
  Purpose

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 Intervention Phase
Osteoarthritis, Knee
Osteoarthritis, Hip
Drug: Celecoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Flare Events Per Time of Exposure to Study Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 875
Study Start Date: July 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139776

  Show 124 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00139776     History of Changes
Other Study ID Numbers: A3191173
Study First Received: August 29, 2005
Results First Received: February 20, 2009
Last Updated: June 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014