Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use" - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00139776

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 Osteoarthritis, Hip	Drug: Celecoxib	Phase IV

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Celecoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

To determine whether "continuous use" over a 6-month period of celecoxib 200 mg per day is more efficacious than "intermittent use" of celecoxib 200 mg per day in reducing the number of spontaneous osteoarthritis flares of the knee or hip joints. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Amount of study flare medication taken [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Time to first arthritis flare from the first dose of study medication [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of days a subject is free from arthritis flare [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of days a subject is in arthritis flare [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Medical Outcomes Study Sleep Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Patient's Assessment of Arthritis Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Patient's Global Assessment of Arthritis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Physician's Global Assessment of Arthritis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Amount of rescue medication (paracetamol/acetaminophen) taken [ Time Frame: 6 months ] [ 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
Celecoxib-: Active Comparator "Continuous use" of celecoxib 200 mg per day	Drug: Celecoxib Treatment: To determine whether "continuous use" over a 6-month period of celecoxib 200 mg per day is more efficacious than "intermittent use" of celecoxib 200 mg per day in preventing spontaneous osteoarthritis flares of the knee and hip joints.
Celecoxib: Active Comparator "Usual or intermittent use"of celecoxib 200 mg per day	Drug: Celecoxib Treatment: To determine whether "continuous use" over a 6-month period of celecoxib 200 mg per day is more efficacious than "intermittent use" of celecoxib 200 mg per day in preventing spontaneous osteoarthritis flares of the knee and hip joints.

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 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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191173
Study First Received:	August 29, 2005
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00139776 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use

Study placed in the following topic categories:

Anti-Inflammatory Agents
Celecoxib
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Pain
Osteoarthritis, Hip
Rheumatic Diseases

Osteoarthritis, Knee
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Osteoarthritis, Hip
Rheumatic Diseases
Pharmacologic Actions

Osteoarthritis, Knee
Musculoskeletal Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Arthritis
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009