OsteoarthritisPhase 3NCT00648258
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 study testing valdecoxib and naproxen in people with Osteoarthritis, run by Pfizer at 4 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- 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
- 130 participants
- Where
- 4 sitesTaiwan
- Study dates
- Jul 2003to Apr 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
- 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"
Who cannot join
- Use of NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) before baseline arthritis assessments
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Pfizer Investigational Site
Kaohsiung City
Pfizer Investigational Site
Kweishan, Taoyuan
Pfizer Investigational Site
Taichung
Pfizer Investigational Site
Taipei
About this study
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
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).
- Conditions
- Osteoarthritis
- Being tested
- valdecoxib, naproxen
- Keywords
- osteoarthritis, knee, osteoarthritis, hip
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip
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 (Osteoarthritis-Pain VAS)
Measured: Week 6
Secondary outcomes (7)
Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index
Measured: Week 2 and Week 6
WOMAC OA physical function
Measured: Week 2 and Week 6
WOMAC OA pain index
Measured: Week 2 and Week 6
WOMAC OA stiffness index
Measured: Week 2 and Week 6
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
Measured: Week 2
Patient's Global Assessment of Arthritis
Measured: Week 2 and Week 6
Physician's Global Assessment of Arthritis
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 posted1 Apr 2008 (estimated)
- Study startJul 2003
- Study completionApr 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 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
- NCT00648258
- Sponsor's protocol ID
- VALA-0513-141
- Other IDs
- A3471101
- Status last verified
- Dec 2018
- First submitted
- 28 Mar 2008
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00648258
- Acronym / sponsor ID
- VALA-0513-141
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, knee, osteoarthritis, hip
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Study completion
- Apr 2004 (actual)
- First posted
- 1 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- 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)
- 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"
Key exclusion criteria (1 listed)
- Use of NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) before baseline arthritis assessments
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 (Osteoarthritis-Pain VAS)
Time frame: Week 6
7 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index
Time frame: Week 2 and Week 6
WOMAC OA physical function
Time frame: Week 2 and Week 6
WOMAC OA pain index
Time frame: Week 2 and Week 6
WOMAC OA stiffness index
Time frame: Week 2 and Week 6
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
Time frame: Week 2
Patient's Global Assessment of Arthritis
Time frame: Week 2 and Week 6
Physician's Global Assessment of Arthritis
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 5 Dec 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Osteoarthritis
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
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
4 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, run by Pfizer at 4 sites in Taiwan.
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 1 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 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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 (Osteoarthritis-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 5 Dec 2018.