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Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anyang, , 431-070 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Knee
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Korean outpatients with symptomatic radiologic evidence of OA of the knee (diagnosed
according to the modified American College Rheumatology criteria)

- Patient's Assessment of Arthritis Pain measurement of at least 40 mm on VAS

- Patients had not received any NSAIDs or analgesics within 2 days (within 4 days for
subjects taking oxaprozin, piroxicam or full dose aspirin) prior to the Baseline Visit

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Diagnosis of inflammatory arthritis, gout, pseudogout, Paget's disease, or any chronic
pain syndrome that, in the Investigator's opinion, would interfere with the assessment
of the Index Knee

- Symptomatic anserine bursitis or acute joint trauma of the Index Knee

- Arthroscopy performed on the Index Knee within the past 12 months

- Complete loss of articular cartilage of the Index Knee

- Administration of oral, or intramuscular, intravenous, or soft tissue injections of
corticosterosteroids within 4 weeks prior to screening visit

- Administration of intra-articular injection of corticosteroids or hyaluronic acid
preparation in the Index Knee within 3 months or 6 months, respectively

NCT00652808
Pfizer
Completed
Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee

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Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee
Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg QD and Naproxen 500 mg BID in Treating the Signs and Symptoms of Osteoarthritis of the Knee
This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal anti-inflammatory drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA of the knee.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis
  • Knee
  • Drug: valdecoxib
    valdecoxib 10 mg tablet by mouth once daily for 6 weeks
  • Drug: naproxen
    naproxen 500 mg capsule by mouth twice daily for 6 weeks
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: naproxen
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
265
September 2004
Not Provided

Inclusion Criteria:

  • Korean outpatients with symptomatic radiologic evidence of OA of the knee (diagnosed according to the modified American College Rheumatology criteria)
  • Patient's Assessment of Arthritis Pain measurement of at least 40 mm on VAS
  • Patients had not received any NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) prior to the Baseline Visit

Exclusion Criteria:

  • Diagnosis of inflammatory arthritis, gout, pseudogout, Paget's disease, or any chronic pain syndrome that, in the Investigator's opinion, would interfere with the assessment of the Index Knee
  • Symptomatic anserine bursitis or acute joint trauma of the Index Knee
  • Arthroscopy performed on the Index Knee within the past 12 months
  • Complete loss of articular cartilage of the Index Knee
  • Administration of oral, or intramuscular, intravenous, or soft tissue injections of corticosterosteroids within 4 weeks prior to screening visit
  • Administration of intra-articular injection of corticosteroids or hyaluronic acid preparation in the Index Knee within 3 months or 6 months, respectively
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00652808
A3471045
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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