Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial I
Public ClinicalTrials.gov record NCT00546507. 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.
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 I
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
- NCT00546507
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 650 participants
Conditions and interventions
Conditions
Interventions
- TDS-943 (topical diclofenac sodium 4% spray) Drug
- celecoxib Drug
- placebo Other
Drug · Other
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
- Oct 2007 (Type not available)
- Primary completion
- Oct 2008 (Actual)
- Completion
- Oct 2008 (Actual)
- Last update posted
- Oct 13, 2010
2007 – 2008
United States locations
- U.S. sites
- 43
- U.S. states
- 16
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Huntsville | Alabama | 35801 | — |
| Not listed | Mobile | Alabama | 36608 | — |
| Not listed | Mesa | Arizona | 85206 | — |
| Not listed | Tucson | Arizona | 85710 | — |
| Not listed | Tucson | Arizona | 85741 | — |
| Not listed | Fair Oaks | California | 95628 | — |
| Not listed | Pico Rivera | California | 90660 | — |
| Not listed | Santa Barbara | California | 93108 | — |
| Not listed | Torrance | California | 90505 | — |
| Not listed | DeLand | Florida | 32720 | — |
| Not listed | Jacksonville | Florida | 32259 | — |
| Not listed | Kissimmee | Florida | 34741 | — |
| Not listed | Ocala | Florida | 34474 | — |
| Not listed | Ormond Beach | Florida | 32174 | — |
| Not listed | Pembroke Pines | Florida | 33024 | — |
| Not listed | Pinellas Park | Florida | 33781 | — |
| Not listed | Stuart | Florida | 34996 | — |
| Not listed | Tampa | Florida | 33614 | — |
| Not listed | Tampa | Florida | 33615 | — |
| Not listed | Atlanta | Georgia | 30308 | — |
| Not listed | Atlanta | Georgia | 30329 | — |
| Not listed | Atlanta | Georgia | 30342 | — |
| Not listed | Chicago | Illinois | 60612 | — |
| Not listed | Gurnee | Illinois | 60031 | — |
| Not listed | Morton | Illinois | 61550 | — |
| Not listed | Peoria | Illinois | 61614 | — |
| Not listed | Evansville | Indiana | 47714 | — |
| Not listed | Baton Rouge | Louisiana | 70809 | — |
| Not listed | Florissant | Missouri | 63031 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Raleigh | North Carolina | 27612 | — |
| Not listed | Winston-Salem | North Carolina | 27103 | — |
| Not listed | Cincinnati | Ohio | 45219 | — |
| Not listed | Columbus | Ohio | 43212 | — |
| Not listed | Perrysburg | Ohio | 43551 | — |
| Not listed | Wallingford | Pennsylvania | 19086 | — |
| Not listed | Cranston | Rhode Island | 02920 | — |
| Not listed | Cordova | Tennessee | 38018 | — |
| Not listed | Memphis | Tennessee | 38119 | — |
| Not listed | Dallas | Texas | 75231 | — |
| Not listed | Dallas | Texas | 75235 | — |
| Not listed | San Antonio | Texas | 78205 | — |
| Not listed | Roanoke | Virginia | 24018 | — |
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 NCT00546507, 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 13, 2010 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00546507 live on ClinicalTrials.gov.