NCT00652808

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
Last Updated

April 10, 2008

Status Verified

April 1, 2008

First QC Date

April 1, 2008

Last Update Submit

April 7, 2008

Conditions

OsteoarthritisKnee

Keywords

knee, OA patients

Outcome Measures

Primary Outcomes (1)

  • Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)

    Week 6

Secondary Outcomes (8)

  • WOMAC OA Physical Function

    Week 2 and Week 6

  • WOMAC OA Stiffness Index

    Week 2 and Week 6

  • Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)

    Week 2

  • Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)

    Week 2 and Week 6

  • adverse events

    Continuous

  • +3 more secondary outcomes

Study Arms (2)

Arm 1

ACTIVE COMPARATOR
Drug: valdecoxib

Arm 2

ACTIVE COMPARATOR
Drug: naproxen

Interventions

valdecoxibDRUG

valdecoxib 10 mg tablet by mouth once daily for 6 weeks

Arm 1
naproxenDRUG

naproxen 500 mg capsule by mouth twice daily for 6 weeks

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Pfizer Investigational Site

Anyang, 431-070, South Korea

Location

Pfizer Investigational Site

Gwangju, 501-757, South Korea

Location

Pfizer Investigational Site

Incheon, 405-760, South Korea

Location

Pfizer Investigational Site

Pusan, 602-739, South Korea

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 137-701, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Seoul, 152-703, South Korea

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis

Interventions

valdecoxibNaproxen

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 4, 2008

Study Start

May 1, 2004

Study Completion

September 1, 2004

Last Updated

April 10, 2008

Record last verified: 2008-04

Locations

KR(8)