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)
NCT ID: NCT00650624
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
416 participants
INTERVENTIONAL
2003-06-30
2004-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
valdecoxib
valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
Arm 2
valdecoxib
valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
Arm 3
valdecoxib
valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks
Arm 4
placebo
placebo tablet by mouth once daily in the morning for 6 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
valdecoxib
valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
valdecoxib
valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
valdecoxib
valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks
placebo
placebo tablet by mouth once daily in the morning for 6 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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"
Exclusion Criteria
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pfizer, Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Funabashi, Chiba, Japan
Pfizer Investigational Site
Sakura, Chiba, Japan
Pfizer Investigational Site
Chikushi-gun, Fukuoka, Japan
Pfizer Investigational Site
Iizuka, Fukuoka, Japan
Pfizer Investigational Site
Kurume, Fukuoka, Japan
Pfizer Investigational Site
Yame, Fukuoka, Japan
Pfizer Investigational Site
Chitose, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Kamakura, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Isahaya, Nagasaki, Japan
Pfizer Investigational Site
Hirakata, Osaka, Japan
Pfizer Investigational Site
Kanzaki-gun, Saga-ken, Japan
Pfizer Investigational Site
Karatsu, Saga-ken, Japan
Pfizer Investigational Site
Ogi-gun, Saga-ken, Japan
Pfizer Investigational Site
Itabashi-ku, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-Ku, Tokyo, Japan
Pfizer Investigational Site
Taito-ku, Tokyo, Japan
Pfizer Investigational Site
Yoyogi Shibuya-ku, Tokyo, Japan
Pfizer Investigational Site
Saga, , Japan
Pfizer Investigational Site
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A3471090
Identifier Type: -
Identifier Source: secondary_id
VALAJP-8274-156
Identifier Type: -
Identifier Source: org_study_id