A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00648258

Purpose

To evaluate the efficacy, safety, and tolerability of valdecoxib by comparing valdecoxib 10 mg daily (QD) with naproxen 500 mg twice daily (BID) in treating the signs and symptoms of osteoarthritis (OA) of the knee or hip. The study was designed to collect comparative information for the local population (Taiwan).

Condition	Intervention	Phase
Osteoarthritis	Drug: valdecoxib Drug: naproxen	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg QD And Naproxen 500mg BID In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium Valdecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
WOMAC OA physical function [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
WOMAC OA pain index [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
WOMAC OA stiffness index [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
Patient's Global Assessment of Arthritis [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
Physician's Global Assessment of Arthritis [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]

Enrollment:	130
Study Start Date:	July 2003
Study Completion Date:	April 2004

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: valdecoxib valdecoxib 10 mg tablet by mouth once daily for 6 weeks
Arm 2: Active Comparator	Drug: naproxen naproxen 500 mg capsule by mouth twice daily for 6 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The diagnosis of hip OA, which was having hip pain and meeting criteria for at least 2 of the following: a. Westergren erythrocyte sedimentation rate of < 20 mm/hr; b. radiographic femoral or acetabular osteophytes or c. radiographic joint space narrowing
Knee OA diagnosis required diagnosing (by modified American College of Rheumatology criteria) OA of the knee with pain plus at least one of the following: a. Age> 50 years old, b. Stiffness < 30 minutes, c. crepitus on active motion and radiographic evidence of OA of the knee, defined as presence of osteophytes or joint space narrowing
Symptomatic OA of the knee or hip was determined at the Baseline Visit, if the Patient's Assessment of Arthritis Pain was at least 40 mm VAS, Patient's and the Physician's Global Assessment of Arthritis was "poor" or "very poor"

Exclusion Criteria:

Use of NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) before baseline arthritis assessments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648258

Locations

Taiwan, Taoyuan
Pfizer Investigational Site
Kweishan, Taoyuan, Taiwan
Taiwan
Pfizer Investigational Site
Kaohsiung, Taiwan
Pfizer Investigational Site
Taichung, Taiwan
Pfizer Investigational Site
Taipei, Taiwan

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

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
ClinicalTrials.gov Identifier:	NCT00648258 History of Changes
Other Study ID Numbers:	VALA-0513-141, A3471101
Study First Received:	March 28, 2008
Last Updated:	April 7, 2008
Health Authority:	Taiwan: Department of Health

Keywords provided by Pfizer:

osteoarthritis, knee
osteoarthritis, hip

Additional relevant MeSH terms:

Osteoarthritis
Signs and Symptoms
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Valdecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2010