A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee

December 19, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

Objectives: Primary:To assess the efficacy and safety of PLA-695 in subjects with active osteoarthritis (OA) of the knee.

Secondary:To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among dose levels. To assess health outcome measures. To assess the effect of PLA-695 on biomarkers related to clinical responses. To assess PLA-695 exposure-response relationship on PD, efficacy, and safety measures. To assess pharmacogenomics (PGX) analysis in OA.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, randomized, double-blind, double-dummy, parallel, placebo- and positive-control (naproxen), dose-ranging study to assess the efficacy and safety of 3 oral doses of PLA-695 administered QD and 1 dose of PLA-695 administered BID for 6 weeks. Subjects will be randomized to 1 of 6 treatment groups: PLA-695 50 mg, 200 mg, or 400 mg QD, PLA-695 200 mg BID, placebo, or naproxen 500 mg BID. Subjects will undergo a washout period of 2 to 14 days. The number of days for washout will be determined by the pre-study NSAID of each subject. Subjects who washout from previous therapy with an increase in signs and symptoms of OA will be randomly assigned to receive PLA-695.

Study Type

Interventional

Enrollment

560

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1122
      • Capital Federal, Buenos Aires, Argentina, 1180
    • Cordoba
      • Cordoba-Capital, Cordoba, Argentina, 5000
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
  • Brazil
      • Sao Paulo, Brazil, 04020-060
  • Canada
      • Quebec, Canada, G1W 4R4
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
      • Kelowna, British Columbia, Canada, V1Y 3G8
      • Langley, British Columbia, Canada
      • Penticton, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
    • Ontario
      • Hamilton, Ontario, Canada, L8M 1K7
      • Kitchener, Ontario, Canada, N2M 5N6
      • London, Ontario, Canada, N6A 4V2
      • Ottawa, Ontario, Canada, K1H 1A2
      • Sarnia, Ontario, Canada, N7T 4X3
      • Toronto, Ontario, Canada, M4N 3M5
    • Quebec
      • Montreal, Quebec, Canada, H3Z 2Z3
      • Montreal, Quebec, Canada, H1T 4B3
      • Montreal, Quebec, Canada, H1L 6J5
      • Pointe-Claire, Quebec, Canada, H9R 3J1
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
  • Hong Kong
      • Hong Kong, Hong Kong
  • Hungary
      • Bekescsaba, Hungary, H-5600
      • Budapest, Hungary, H-1036
      • Debrecen, Hungary
      • Kiskunhalas, Hungary, H-6400
      • Nyiregyhaza, Hungary
  • Mexico
      • Mexico City, Mexico, 6700
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44620
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64020
  • Netherlands
      • Almere, Netherlands, 1311 RL
      • Geleen, Netherlands, 6160 BB
      • Hertogenbosch, Netherlands, 5233 VG
      • Nijmegen, Netherlands, 6525 EC
  • Poland
      • Krakow, Poland, 30-119
      • Krakow, Poland, 31-121
      • Szczecin, Poland
      • Warszawa, Poland, 02-637
      • Wroclaw, Poland, 53-347
  • Spain
      • Guadalajara, Spain, 19002
      • La Coruna, Spain, 15006
      • Madrid, Spain, 28046
      • Sevilla, Spain, 41009
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
    • Arizona
      • Scottsdale, Arizona, United States, 85251
      • Tucson, Arizona, United States
      • Tucson, Arizona, United States, 85704
    • California
      • Palo Alto, California, United States, 94304
      • Rancho Mirage, California, United States, 92270
      • Santa Maria, California, United States, 93455
      • Upland, California, United States, 91786
    • Florida
      • Delray Beach, Florida, United States, 33484
      • Fort Lauderdale, Florida, United States, 33334
      • Ocala, Florida, United States, 34474
      • Palm Harbor, Florida, United States, 34684
      • South Miami, Florida, United States, 33143
      • Tampa, Florida, United States, 33614
    • Idaho
      • Idaho Falls, Idaho, United States, 83401
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Kansas
      • Wichita, Kansas, United States, 67208
    • Maryland
      • Baltimore, Maryland, United States, 21224
      • Frederick, Maryland, United States, 21702
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
    • Missouri
      • St. Louis, Missouri, United States, 63128
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
    • New York
      • Mamaroneck, New York, United States, 10543
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
      • West Reading, Pennsylvania, United States, 19611
      • Willow Grove, Pennsylvania, United States, 19090
    • South Carolina
      • Charleston, South Carolina, United States, 29406
    • Texas
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75235
      • San Antonio, Texas, United States, 78217
    • Utah
      • Salt Lake City, Utah, United States, 84107
    • Washington
      • Seattle, Washington, United States, 98166
      • Spokane, Washington, United States, 99204
      • Tacoma, Washington, United States, 98405
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
WOMAC VAS walking pain (question 1) at week 6 is the primary endpoint.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trial Manager, For Poland, WPWZMED@wyeth.com
  • Principal Investigator: Trial Manager, For Spain, infomed@wyeth.com
  • Principal Investigator: Trial Manager, For Brazil, xavierl@wyeth.com
  • Principal Investigator: Trial manager, For Hungary, WPBUMED@wyeth.com
  • Principal Investigator: Trial Manager, For Mexico, gomezzlj@wyeth.com
  • Principal Investigator: Trial Manager, For Argentina, Scheima@wyeth.com
  • Principal Investigator: Trial Manager, For Hong Kong, medinfo@wyeth.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

November 7, 2006

First Submitted That Met QC Criteria

November 7, 2006

First Posted (Estimate)

November 8, 2006

Study Record Updates

Last Update Posted (Estimate)

December 28, 2007

Last Update Submitted That Met QC Criteria

December 19, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3175A1-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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