Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
Public ClinicalTrials.gov record NCT00504127. 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
A Phase 3, 53 Weeks Study on Analgesic Efficacy and Safety of Naproxcinod (HCT 3012): 26-Week, Randomized, Parallel-Group, Double-Blind, Placebo (13 Weeks)- and Naproxen (26 Weeks)-Controlled, Multicenter Study of Naproxcinod (375 mg Bid and 750 mg Bid) With a 26-Week Naproxen-Controlled Safety Follow-up in Subjects With Osteoarthritis of the Knee, and a 1-week Post-treatment Safety Follow-up
Study identification
- NCT ID
- NCT00504127
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- NicOx
- Industry
- Enrollment
- 1,020 participants
Conditions and interventions
Conditions
Interventions
- Naproxcinod 375 mg bid Drug
- Naproxcinod 750 mg bid Drug
- Naproxen 500 mg bid Drug
- placebo Drug
Drug
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
- Mar 31, 2007
- Primary completion
- Nov 30, 2008
- Completion
- Not listed
- Last update posted
- Jun 16, 2011
Started 2007
United States locations
- U.S. sites
- 73
- U.S. states
- 27
- U.S. cities
- 73
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Chandler | Arizona | — | — |
| Not listed | Tempe | Arizona | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Anaheim | California | — | — |
| Not listed | Encino | California | — | — |
| Not listed | Foothill Ranch | California | — | — |
| Not listed | Orange | California | — | — |
| Not listed | Rancho Mirage | California | — | — |
| Not listed | Riverside | California | — | — |
| Not listed | Denver | Colorado | — | — |
| Not listed | Waterbury | Connecticut | — | — |
| Not listed | Boca Raton | Florida | — | — |
| Not listed | Brooksville | Florida | — | — |
| Not listed | DeLand | Florida | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Largo | Florida | — | — |
| Not listed | Ocala | Florida | — | — |
| Not listed | Pinellas Park | Florida | — | — |
| Not listed | St. Petersburg | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Athens | Georgia | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Marietta | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Rockford | Illinois | — | — |
| Not listed | Prairie Village | Kansas | — | — |
| Not listed | Wichita | Kansas | — | — |
| Not listed | Erlanger | Kentucky | — | — |
| Not listed | Louisville | Kentucky | — | — |
| Not listed | Baton Rouge | Louisiana | — | — |
| Not listed | Owings Mills | Maryland | — | — |
| Not listed | Wellesley Hills | Massachusetts | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | Brooklyn Center | Minnesota | — | — |
| Not listed | Edina | Minnesota | — | — |
| Not listed | Florissant | Missouri | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Rochester | New York | — | — |
| Not listed | Asheville | North Carolina | — | — |
| Not listed | Charlotte | North Carolina | — | — |
| Not listed | Concord | North Carolina | — | — |
| Not listed | Raleigh | North Carolina | — | — |
| Not listed | Salisbury | North Carolina | — | — |
| Not listed | Winston-Salem | North Carolina | — | — |
| Not listed | Beachwood | Ohio | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Marion | Ohio | — | — |
| Not listed | Clinton | Oklahoma | — | — |
| Not listed | Altoona | Pennsylvania | — | — |
| Not listed | Bensalem | Pennsylvania | — | — |
| Not listed | Duncansville | Pennsylvania | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | West Reading | Pennsylvania | — | — |
| Not listed | Anderson | South Carolina | — | — |
| Not listed | Clinton | South Carolina | — | — |
| Not listed | Goose Creek | South Carolina | — | — |
| Not listed | Greer | South Carolina | — | — |
| Not listed | Mt. Pleasant | South Carolina | — | — |
| Not listed | Cordova | Tennessee | — | — |
| Not listed | Jackson | Tennessee | — | — |
| Not listed | Kingsport | Tennessee | — | — |
| Not listed | Memphis | Tennessee | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Garland | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Nederland | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Norfolk | Virginia | — | — |
| Not listed | Roanoke | Virginia | — | — |
| Not listed | Virginia Beach | Virginia | — | — |
| Not listed | Lakewood | Washington | — | — |
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 NCT00504127, 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 Jun 16, 2011 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00504127 live on ClinicalTrials.gov.