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Terminated Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00396955

Public ClinicalTrials.gov record NCT00396955. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 1:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00396955
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Enrollment
560 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
50 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2006 (Type not available)
Primary completion
Nov 2007 (Actual)
Completion
Nov 2007 (Actual)
Last update posted
Dec 28, 2007

2006 – 2007

United States locations

U.S. sites
39
U.S. states
21
U.S. cities
37
Facility City State ZIP Site status
Not listed Huntsville Alabama 35801 —
Not listed Scottsdale Arizona 85251 —
Not listed Tucson Arizona 85704 —
Not listed Tucson Arizona — —
Not listed Palo Alto California 94304 —
Not listed Rancho Mirage California 92270 —
Not listed Santa Maria California 93455 —
Not listed Upland California 91786 —
Not listed Delray Beach Florida 33484 —
Not listed Fort Lauderdale Florida 33334 —
Not listed Ocala Florida 34474 —
Not listed Palm Harbor Florida 34684 —
Not listed South Miami Florida 33143 —
Not listed Tampa Florida 33614 —
Not listed Idaho Falls Idaho 83401 —
Not listed Chicago Illinois 60611 —
Not listed Wichita Kansas 67208 —
Not listed Baltimore Maryland 21224 —
Not listed Frederick Maryland 21702 —
Not listed Fall River Massachusetts 02720 —
Not listed Kalamazoo Michigan 49048 —
Not listed St Louis Missouri 63128 —
Not listed Las Vegas Nevada — —
Not listed Dover New Hampshire 03820 —
Not listed Mamaroneck New York 10543 —
Not listed Syracuse New York 13210 —
Not listed Charlotte North Carolina 28210 —
Not listed Duncansville Pennsylvania 16635 —
Not listed West Reading Pennsylvania 19611 —
Not listed Willow Grove Pennsylvania 19090 —
Not listed Charleston South Carolina 29406 —
Not listed Dallas Texas 75231 —
Not listed Dallas Texas 75235 —
Not listed San Antonio Texas 78217 —
Not listed Salt Lake City Utah 84107 —
Not listed Seattle Washington 98166 —
Not listed Spokane Washington 99204 —
Not listed Tacoma Washington 98405 —
Not listed Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 44 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00396955, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 28, 2007 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00396955 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →