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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00396955 |
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Date of registration:
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07/11/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee
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Scientific title:
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A Multicenter, Randomized, Double-Blind Comparison of 4 Dose Regimens of Pla-695, Naproxen, and Placebo Administered Daily for 6 Weeks in Subjects With Active Osteoarthritis of the Knee |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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560 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00396955 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Brazil
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Canada
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China
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Hong Kong
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Hungary
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Mexico
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Netherlands
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Poland
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Spain
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United States
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Netherlands, trials-NL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Hungary, WPBUMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Poland, WPWZMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Brazil, xavierl@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Mexico, gomezzlj@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Hong Kong, medinfo@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Spain, infomed@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Argentina, Scheima@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For China, medinfo@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria: The main inclusion criteria is listed below, additional inclusion
criteria is in the protocol.
- Men or women 50 to 75 years of age. Women must be of non-childbearing potential.
Sexually active men who are not surgically sterile must agree and commit to use of
barrier contraception during the study and for at least 12 weeks after the last dose
of PLA.
- Diagnosed with idiopathic OA of the knee for at least 3 months duration in accordance
with [1986] American College of Rheumatology (ACR) clinical and radiographic
criteria: knee pain, the presence of osteophytes, and any one of the following: age
>50 years, crepitus, or morning stiffness <30 minutes.
- Radiographic confirmation of OA at the target joint (weight-bearing anteroposterior
and lateral views) within 1 year of screening.
- Must be currently treated for OA with a stable daily dose of 1 NSAID, including COX-2
inhibitors, not exceeding the maximum recommended dose in the product label, and
taken as prescribed by the physician, starting at least 4 weeks before the screening
visit.
Exclusion Criteria: These are some of the main exclusion criteria for the the study.
Additional exclusion are included in the protocol.
- History of or suspected current esophageal or gastrointestinal bleeding, ulcers,
obstruction, or perforation, or pancreatitis.
- Grade 4 severity on the Kellgren-Lawrence Scale on the screening target knee
radiograph.
- Any significant cardiovascular, hematologic, blood dyscrasia, endocrine, respiratory,
neurologic, psychiatric, metabolic, immunologic, infectious, hepatic, or renal
condition that the investigator considers detrimental to the subject's participating
in the study or that may prevent the successful completion of the study.
- Any clinically significant laboratory abnormality.
Age minimum:
50 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Intervention(s)
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Drug: PLA-695
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Primary Outcome(s)
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WOMAC VAS walking pain (question 1) at week 6 is the primary endpoint.
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Secondary Outcome(s)
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WOMAC VAS walking pain at weeks 1, 2, 3, 4, and 5; WOMAC pain, stiffness, and function subscales, and composite score; Investigatorsâ Efficacy Evaluation; Investigatorsâ overall assessment; Joint tenderness. Subjectsâ Efficacy Evaluation.
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Secondary ID(s)
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3175A1-202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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