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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00648258
First Posted: April 1, 2008
Last Update Posted: April 10, 2008
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.
Information provided by:
Pfizer
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS) [ Time Frame: Week 6 ]

Secondary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index [ Time Frame: Week 2 and Week 6 ]
  • WOMAC OA physical function [ Time Frame: Week 2 and Week 6 ]
  • WOMAC OA pain index [ Time Frame: Week 2 and Week 6 ]
  • WOMAC OA stiffness index [ Time Frame: Week 2 and Week 6 ]
  • Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS) [ Time Frame: Week 2 ]
  • Patient's Global Assessment of Arthritis [ Time Frame: Week 2 and Week 6 ]
  • Physician's Global Assessment of Arthritis [ Time Frame: Week 2 and Week 6 ]

Enrollment: 130
Study Start Date: July 2003
Study Completion Date: April 2004
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: valdecoxib
valdecoxib 10 mg tablet by mouth once daily for 6 weeks
Active Comparator: Arm 2 Drug: naproxen
naproxen 500 mg capsule by mouth twice daily for 6 weeks

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00648258


Locations
Taiwan
Pfizer Investigational Site
Kweishan, Taoyuan, 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00648258     History of Changes
Other Study ID Numbers: VALA-0513-141
A3471101
First Submitted: March 28, 2008
First Posted: April 1, 2008
Last Update Posted: April 10, 2008
Last Verified: March 2008

Keywords provided by Pfizer:
osteoarthritis, knee
osteoarthritis, hip

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Signs and Symptoms
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
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors