You are here

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

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Huntsville, Alabama, 35801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00396955
Pfizer
Terminated
A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Osteoarthritis, Cancer Pain, Recurrent Low Back Pain
NCT03031938
All Genders
0+
Years
Multiple Sites
Chronic Pain, Hip Osteoarthritis, Knee Osteoarthritis
NCT02528188
All Genders
18+
Years
Multiple Sites
A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee
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.

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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Osteoarthritis
Drug: PLA-695
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
560
November 2007
November 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Canada,   Hong Kong,   Hungary,   Mexico,   Netherlands,   Poland,   Spain,   United States
China
 
NCT00396955
3175A1-202
Not Provided
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Argentina, [email protected]
Principal Investigator: Trial Manager For Brazil, [email protected]
Principal Investigator: Trial Manager For China, [email protected]
Principal Investigator: Trial Manager For Hong Kong, [email protected]
Principal Investigator: Trial Manager For Hungary, [email protected]
Principal Investigator: Trial Manager For Mexico, [email protected]
Principal Investigator: Trial Manager For Netherlands, [email protected]
Principal Investigator: Trial Manager For Poland, [email protected]
Principal Investigator: Trial Manager For Spain, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now