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Completed Phase 3 Interventional

Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II

ClinicalTrials.gov ID: NCT00546832

Public ClinicalTrials.gov record NCT00546832. 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 Sep 26, 2026, 2:36 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

The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study II

Brief summary

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

The objective of this study is to evaluate the efficacy and safety of TDS-943 (topical diclofenac spray) compared to oral celecoxib and placebo in subjects with osteoarthritis of the knee. The main hypotheses are that TDS-943 will be better than placebo and no worse than celecoxib.

Study identification

NCT ID
NCT00546832
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Mika Pharma GmbH
Industry
Enrollment
650 participants

Conditions and interventions

Eligibility (public fields only)

Age range
40 Years and older
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
Sep 30, 2007
Primary completion
Sep 30, 2008
Completion
Oct 31, 2008
Last update posted
Oct 12, 2010

2007 – 2008

United States locations

U.S. sites
49
U.S. states
26
U.S. cities
45
Facility City State ZIP Site status
Not listed Birmingham Alabama 35209 —
Not listed Birmingham Alabama 35244 —
Not listed Chandler Arizona 85225 —
Not listed Phoenix Arizona 85032 —
Not listed Little Rock Arkansas 72205 —
Not listed Anaheim California 92801 —
Not listed Anaheim California 92804 —
Not listed Foothill Ranch California 92610 —
Not listed Irvine California 92618 —
Not listed Westlake Village California 91361 —
Not listed Denver Colorado 80209 —
Not listed Danbury Connecticut 06810 —
Not listed Milford Connecticut 06460 —
Not listed Stanford Connecticut 06905 —
Not listed Boynton Beach Florida 33472 —
Not listed Delray Beach Florida 33484 —
Not listed New Smyrna Beach Florida 32168 —
Not listed Ococee Florida 34761 —
Not listed Sarasota Florida 34239 —
Not listed St. Petersburg Florida 33702 —
Not listed Blue Ridge Georgia 30513 —
Not listed Marietta Georgia 30066 —
Not listed Savannah Georgia 31406 —
Not listed Boise Idaho 83702 —
Not listed Chicago Illinois 60611 —
Not listed Overland Park Kansas 66202 —
Not listed Towson Maryland 21286 —
Not listed Brockton Massachusetts 02301 —
Not listed Kalamazoo Michigan 49009 —
Not listed Kansas City Missouri 64114 —
Not listed Omaha Nebraska 68144 —
Not listed Berlin New Jersey 08009 —
Not listed Medford New Jersey 08055 —
Not listed Brooklyn New York 11214 —
Not listed Asheville North Carolina 28801 —
Not listed Cincinnati Ohio 45246 —
Not listed Cleveland Ohio 44121 —
Not listed Marion Ohio 43302 —
Not listed Oklahoma City Oklahoma 73103 —
Not listed Oklahoma City Oklahoma 73112 —
Not listed Bensalem Pennsylvania 19020 —
Not listed Duncansville Pennsylvania 16635 —
Not listed Charleston South Carolina 29406 —
Not listed Austin Texas 78704 —
Not listed Nederland Texas 77627 —
Not listed San Antonio Texas 78209 —
Not listed San Antonio Texas 78229 —
Not listed Virginia Beach Virginia 23455 —
Not listed Milwaukee Wisconsin 53209 —

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00546832, 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 Oct 12, 2010 · Synced Sep 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00546832 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →