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

Primary Purpose

Osteoarthritis

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PLA-695

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, arthritis, pain

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00396955

First Posted

November 7, 2006

Last Updated

December 19, 2007

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00396955

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Terminated

Why Stopped

imbalance of gastrointestinal and the lipase events

Study Start Date

November 2006 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

osteoarthritis, arthritis, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

560 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

PLA-695

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: