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CompletedNCT00648258Updated Dec 5, 2018

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

A Phase 3 interventional study of valdecoxib and naproxen in Osteoarthritis, sponsored by Pfizer. Completed at 4 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-05.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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).

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Conditions studied

  • Osteoarthritis

Keywords

  • osteoarthritis, knee
  • osteoarthritis, hip
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In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 130 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
130 participants (actual)

Study arms

  • Active comparator
    Arm 1

    Drug: valdecoxib

  • Active comparator
    Arm 2

    Drug: naproxen

Interventions

  • Drugvaldecoxib

    valdecoxib 10 mg tablet by mouth once daily for 6 weeks

  • Drugnaproxen

    naproxen 500 mg capsule by mouth twice daily for 6 weeks

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What researchers measure

Primary outcomes

  1. Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)

    Time frame: Week 6

Secondary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index

    Time frame: Week 2 and Week 6

  2. WOMAC OA physical function

    Time frame: Week 2 and Week 6

  3. WOMAC OA pain index

    Time frame: Week 2 and Week 6

  4. WOMAC OA stiffness index

    Time frame: Week 2 and Week 6

  5. Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)

    Time frame: Week 2

  6. Patient's Global Assessment of Arthritis

    Time frame: Week 2 and Week 6

  7. Physician's Global Assessment of Arthritis

    Time frame: Week 2 and Week 6

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Study locations

4 sites
  • Pfizer Investigational Site
    Kweishan, Taoyuan, Taiwan
  • Pfizer Investigational Site
    Kaohsiung, Taiwan
  • Pfizer Investigational Site
    Taichung, Taiwan
  • Pfizer Investigational Site
    Taipei, Taiwan
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00648258
Lead sponsor
Pfizer
First posted
Apr 1, 2008
Start date
Jul 2003
Completion
Apr 2004
Last update
Dec 5, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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