Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%
Public ClinicalTrials.gov record NCT01456611. 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 Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium 1% Gel (Anchen Pharmaceuticals, Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of diclofenac sodium topical gel 1% (Anchen Pharmaceuticals, Inc.) compared to the marketed formulation Voltaren® Gel (diclofenac sodium topical gel) 1% (Novartis) in patients with osteoarthritis of the knee. The efficacy of both the Test and Reference formulations will also be compared to the Placebo gel to determine Superiority.
Study identification
- NCT ID
- NCT01456611
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 749 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 35 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 2011 (Type not available)
- Primary completion
- Apr 2012 (Actual)
- Completion
- Apr 2012 (Actual)
- Last update posted
- Jul 12, 2012
2011 – 2012
United States locations
- U.S. sites
- 57
- U.S. states
- 20
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novum Investigator Site | Birmingham | Alabama | — | — |
| Novum Investigator Site | Huntsville | Alabama | — | — |
| Novum Investigator Site | Chandler | Arizona | — | — |
| Novum Investigator Site | Mesa | Arizona | — | — |
| Novum Investigator Site | Phoenix | Arizona | — | — |
| Novum Investigator Site | Tuscon | Arizona | — | — |
| Novum Investigator Site | Little Rock | Arkansas | — | — |
| Novum Investigator Site | Anaheim | California | — | — |
| Novum Investigator Site | Carmichael | California | — | — |
| Novum Investigator Site | Garden Grove | California | — | — |
| Novum Investigator Site | Long Beach | California | — | — |
| Novum Investigator Site | Sacramento | California | — | — |
| Novum Investigator Site | San Diego | California | — | — |
| Novum Investigator Site | Stock Bridge | California | — | — |
| Novum Investigator Site | Denver | Colorado | — | — |
| Novum Investigator Site | Norwalk | Connecticut | — | — |
| Novum Investigator Site | Stamford | Connecticut | — | — |
| Novum Investigator Site | Adventura | Florida | — | — |
| Novum Investigator Site | Bookville | Florida | — | — |
| Novum Investigator Site | Bradenton | Florida | — | — |
| Novum Investigator Site | Daytona Beach | Florida | — | — |
| Novum Investigator Site | Hialeah | Florida | — | — |
| Novum Investigator Site | Jupiter | Florida | — | — |
| Novum Investigator Site | Miami | Florida | — | — |
| Novum Investigator Site | Ormond Beach | Florida | — | — |
| Novum Investigator Site | Pinellas Park | Florida | — | — |
| Novum Investigator Site | Sarasota | Florida | — | — |
| Novum Investigator Site | St. Petersburg | Florida | — | — |
| Novum Investigator Site | Tampa | Florida | — | — |
| Novum Investigator Site | Marietta | Georgia | — | — |
| Novum Investigator Site | Sandy Springs | Georgia | — | — |
| Novum Investigator Site | Lexington | Kentucky | — | — |
| Novum Investigator Site | New Orleans1 | Louisiana | — | — |
| Novum Investigator Site | Hollywood | Maryland | — | — |
| Novum Investigator Site | Billings | Montana | — | — |
| Novum Investigator Site | Henderson | Nevada | — | — |
| Novum Investigator Site | Cary | North Carolina | — | — |
| Novum Investigator Site | Charlotte | North Carolina | — | — |
| Novum Investigator Site | Hickory | North Carolina | — | — |
| Novum Investigator Site | High Point | North Carolina | — | — |
| Novum Investigator Site | Raleigh | North Carolina | — | — |
| Novum Investigator Site | Salisbury | North Carolina | — | — |
| Novum Investigator Site | Wilmington | North Carolina | — | — |
| Novum Investigator Site | Winston-Salem | North Carolina | — | — |
| Novum Investigator Site | Cleveland | Ohio | — | — |
| Novum Investigator Site | Columbus | Ohio | — | — |
| Novum Investigator Site | Beavercreek | Oklahoma | — | — |
| Novum Investigator Site | Norman | Oklahoma | — | — |
| Novum Investigator Site | Duncansville | Pennsylvania | — | — |
| Novum Investigator Site | Chattanooga | Tennessee | — | — |
| Novum Investigator Site | Houston | Texas | — | — |
| Novum Investigator Site | Longview | Texas | — | — |
| Novum Investigator Site | San Antonio | Texas | — | — |
| Novum Investigator Site | Sugar Land | Texas | — | — |
| Novum Investigator Site | Charlottesville | Virginia | — | — |
| Novum Investigator Site | Midlothian | Virginia | — | — |
| Novum Investigator Site | Newport News | Virginia | — | — |
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 NCT01456611, 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 Jul 12, 2012 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01456611 live on ClinicalTrials.gov.