OsteoarthritisPhase 3NCT00652808
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
A Phase 3 study testing valdecoxib and naproxen in people with Osteoarthritis and Knee, run by Pfizer at 8 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- valdecoxib and naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 8 sitesSouth Korea
- Study dates
- May 2004to Sep 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Pfizer Investigational Site
Anyang, 431-070
Pfizer Investigational Site
Gwangju, 501-757
Pfizer Investigational Site
Incheon, 405-760
Pfizer Investigational Site
Pusan, 602-739
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 137-701
Pfizer Investigational Site
Seoul, 138-736
Pfizer Investigational Site
Seoul, 152-703
About this study
Official title: 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- valdecoxib, naproxen
- Keywords
- knee, OA patients
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valdecoxibDrug
valdecoxib 10 mg tablet by mouth once daily for 6 weeks
naproxenDrug
naproxen 500 mg capsule by mouth twice daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: valdecoxib |
| Arm 2 | Active comparator | Not described Receives: Drug: naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Measured: Week 6
Secondary outcomes (8)
WOMAC OA Physical Function
Measured: Week 2 and Week 6
WOMAC OA Stiffness Index
Measured: Week 2 and Week 6
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Measured: Week 2
Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Measured: Week 2 and Week 6
adverse events
Measured: Continuous
Physician's Global Assessment of Arthritis Pain
Measured: Week 2 and Week 6
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index
Measured: Week 2 and Week 6
WOMAC OA Pain Index
Measured: Week 2 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startMay 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652808
- Sponsor's protocol ID
- A3471045
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 10 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00652808
- Acronym / sponsor ID
- A3471045
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee, OA patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Sep 2004 (actual)
- First posted
- 4 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: valdecoxib |
| Arm 2 | Active comparator | Drug: naproxen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valdecoxibvaldecoxib 10 mg tablet by mouth once daily for 6 weeks | Drug | Arm 1 |
| naproxennaproxen 500 mg capsule by mouth twice daily for 6 weeks | Drug | Arm 2 |
Primary outcome
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Time frame: Week 6
8 secondary outcomes
WOMAC OA Physical Function
Time frame: Week 2 and Week 6
WOMAC OA Stiffness Index
Time frame: Week 2 and Week 6
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Time frame: Week 2
Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Time frame: Week 2 and Week 6
adverse events
Time frame: Continuous
Physician's Global Assessment of Arthritis Pain
Time frame: Week 2 and Week 6
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index
Time frame: Week 2 and Week 6
WOMAC OA Pain Index
Time frame: Week 2 and Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing valdecoxib and naproxen in people with Osteoarthritis and Knee, run by Pfizer at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2008.