A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg Once Daily Versus Placebo In Patients With Osteoarthritis Of The Knee (Japan)

A Phase 2 study testing valdecoxib in people with Osteoarthritis, Knee, run by Pfizer at 22 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To determine the therapeutic dose range of valdecoxib by comparing the efficacy of three dosing regimens (5 mg, 10 mg and 20 mg once daily) with placebo for relief of the signs and symptoms of osteoarthritis of the knee. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: valdecoxib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 416 participants
Where: 22 sitesJapan
Study dates: Jun 2003to Jan 2004
Phase: Phase 2
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed with symptomatic OA of the knee by the American College of Rheumatology (ACR) criteria and a Functional Capacity Classification (FCC) of I - III at Screening Visit and were walking
At the Baseline visit, eligible patients were to have Patient's Assessment of Arthritis Pain VAS ≥ 40 mm and Patient's \& Physician's Global Assessment of Arthritis of "Poor" or "Very Poor"

Who cannot join

Patients unable to walk generally

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

Japan22 sites

Pfizer Investigational Site
Chikushi-gun, Fukuoka
Pfizer Investigational Site
Chitose, Hokkaido
Pfizer Investigational Site
Funabashi, Chiba
Pfizer Investigational Site
Hirakata, Osaka
Pfizer Investigational Site
Iizuka, Fukuoka
Pfizer Investigational Site
Isahaya, Nagasaki
Pfizer Investigational Site
Kamakura, Kanagawa
Pfizer Investigational Site
Kanzaki-gun, Saga-ken
Pfizer Investigational Site
Karatsu, Saga-ken
Pfizer Investigational Site
Kurume, Fukuoka
Pfizer Investigational Site
Ogi-gun, Saga-ken
Pfizer Investigational Site
Saga
Pfizer Investigational Site
Sakura, Chiba
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Setagaya-ku, Tokyo
Pfizer Investigational Site
Shinjuku-Ku, Tokyo
Pfizer Investigational Site
tabashi City, Tokyo
Pfizer Investigational Site
Taito-ku, Tokyo
Pfizer Investigational Site
Tokyo
Pfizer Investigational Site
Yame, Fukuoka
Pfizer Investigational Site
Yokohama, Kanagawa
Pfizer Investigational Site
Yoyogi Shibuya-ku, Tokyo

Other trials in Japan

About this study

Official title: A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg QD Versus Placebo In Patients With OA Of The Knee

Conditions: Osteoarthritis, Knee
Being tested: valdecoxib, placebo
Keywords: knee osteoarthritis; Japan
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

valdecoxibDrug
valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
valdecoxibDrug
valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
valdecoxibDrug
valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks
placeboDrug
placebo tablet by mouth once daily in the morning for 6 weeks

Study groups in NCT00650624
Study group	Role	What they receive
Arm 1	Active comparator	Not described Receives: Drug: valdecoxib
Arm 2	Active comparator	Not described Receives: Drug: valdecoxib
Arm 3	Active comparator	Not described Receives: Drug: valdecoxib
Arm 4	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

WOMAC (Western Ontario and McMaster Universities) OA Pain Index
Measured: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit)

Secondary outcomes (7)

patients' and physicians' and 'categorical' global assessment of arthritis
Measured: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA stiffness index
Measured: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA physical function index
Measured: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA composite index
Measured: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA pain index, stiffness index, physical function index, and composite index
Measured: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Incidence of and time to withdrawal due to lack of efficacy
Measured: weeks 2, 4, and 6
patient's assessment of arthritis pain (Visual Analog Scale, VAS)
Measured: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2003Jan 2004

First posted2 Apr 2008 (estimated)
Study startJun 2003
Study completionJan 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Osteoarthritis, KneeStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 416 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00650624
Sponsor's protocol ID: VALAJP-8274-156
Other IDs: A3471090
Status last verified: Dec 2018
First submitted: 31 Mar 2008
Last updated: 11 Dec 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg QD Versus Placebo In Patients With OA Of The Knee
ClinicalTrials.gov ID: NCT00650624
Acronym / sponsor ID: VALAJP-8274-156
Conditions: Osteoarthritis, Knee
Keywords: knee osteoarthritis; Japan
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 416 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2003
Study completion: Jan 2004 (actual)
First posted: 2 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Arm 1	Active comparator	Drug: valdecoxib
Arm 2	Active comparator	Drug: valdecoxib
Arm 3	Active comparator	Drug: valdecoxib
Arm 4	Placebo comparator	Drug: placebo

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients diagnosed with symptomatic OA of the knee by the American College of Rheumatology (ACR) criteria and a Functional Capacity Classification (FCC) of I - III at Screening Visit and were walking
At the Baseline visit, eligible patients were to have Patient's Assessment of Arthritis Pain VAS ≥ 40 mm and Patient's \& Physician's Global Assessment of Arthritis of "Poor" or "Very Poor"

Key exclusion criteria (1 listed)

Patients unable to walk generally

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 5 mg tablet by mouth once daily in the morning for 6 weeks	Drug	Arm 1
valdecoxibvaldecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks	Drug	Arm 2
valdecoxibvaldecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks	Drug	Arm 3
placeboplacebo tablet by mouth once daily in the morning for 6 weeks	Drug	Arm 4

Primary outcome

WOMAC (Western Ontario and McMaster Universities) OA Pain Index
Time frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit)

7 secondary outcomes

patients' and physicians' and 'categorical' global assessment of arthritis
Time frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA stiffness index
Time frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA physical function index
Time frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA composite index
Time frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA pain index, stiffness index, physical function index, and composite index
Time frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Incidence of and time to withdrawal due to lack of efficacy
Time frame: weeks 2, 4, and 6
patient's assessment of arthritis pain (Visual Analog Scale, VAS)
Time frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 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 11 Dec 2018.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Osteoarthritis, Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

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

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing valdecoxib in people with Osteoarthritis, Knee, run by Pfizer at 22 sites in Japan.

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 2 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 11 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 22 sites in Japan. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

WOMAC (Western Ontario and McMaster Universities) OA Pain Index (time frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00650624.

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 11 Dec 2018.