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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00648258
First received: March 28, 2008
Last updated: April 7, 2008
Last verified: March 2008
  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
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:


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
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

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
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: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
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
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014