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

NCT00396955 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2007-12-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PLA-695

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Hong Kong
  • Hungary
  • Mexico
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00396955 on ClinicalTrials.gov