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This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac Sodium Gel | Drug | 4 grams per knee, 4 times per day, for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| pain in the target knee (WOMAC pain index); | ||
| functional capacity in the target knee (WOMAC function index); and | ||
| global rating of benefit (100 mm Visual Analogue Scale, VAS). |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Diclofenac Sodium Gel 1% with regard attainment of: | ||
| Low pain intensity in either knee; and | ||
| Low functional impairment in either knee. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy Altman, MD | University of California, in Los Angeles, Division of Rheumatology, 310 206 7866 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Clinical Research Inc | Mobile | Alabama | 33608 | United States | ||
| River Region Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21174485 | Derived | Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011 Jan 1;28(1):27-40. doi: 10.2165/11584880-000000000-00000. |
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| Placebo |
| Drug |
4 grams per knee, 4 times per day, for 12 weeks |
|
| Safety of Diclofenac Sodium Gel 1% assessed by: |
| monitoring adverse events; and |
| laboratory evaluations. |
| Tallassee |
| Alabama |
| 36078 |
| United States |
| East Valley Family Physicians | Chandler | Arizona | 85224 | United States |
| HOPE Research Institute | Phoenix | Arizona | 85050 | United States |
| Heartland Research Associates LLC | Arkansas City | Arkansas | 67005 | United States |
| Lovelace Scientific Research, Inc. | Beverly Hills | California | 92011 | United States |
| MED Investigations | Carmichael | California | 95608 | United States |
| MED Investigations, Inc. | Fair Oaks | California | 95628 | United States |
| Universal BioPharma Research, Inc. | Fresno | California | 93703 | United States |
| Santa Barbara Clinical Research, Inc | Santa Barbara | California | 93108 | United States |
| Pacific Arthritis Center Medical Group | Santa Maria | California | 93454 | United States |
| Clinical Research Consultants, LLC | Stratford | Connecticut | 06615 | United States |
| Seidman Clinical Trials | Delray Beach | Florida | 33484 | United States |
| Florida Medical Research Institute | Gainesville | Florida | 32607 | United States |
| South Florida Clinical Research Center | Hollywood | Florida | 33023 | United States |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | United States |
| Suncoast Internal Medicine Consultants | Largo | Florida | 33774 | United States |
| AppleMed Research, Inc. | Miami | Florida | 33155 | United States |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | United States |
| Sunshine Research Center, LLC | Opa-locka | Florida | 33056 | United States |
| Peninsula Research, Inc. | Ormond Beach | Florida | 32174 | United States |
| University Clinical Research, Inc. | Pembroke Pines | Florida | 33024 | United States |
| Andres Patron DO PA | Pembroke Pines | Florida | 33028 | United States |
| Radiant Research - St Petersburg | Pinellas Park | Florida | 33781 | United States |
| Sunrise Medical Research | Plantation | Florida | 33324 | United States |
| Coastal Medical Research | Port Orange | Florida | 32127 | United States |
| Radiant Research | Stuart | Florida | 34996 | United States |
| Intermountain Orthopaedics | Boise | Idaho | 83702 | United States |
| Medical Specialists Clinical Research Center | Munster | Indiana | 46321 | United States |
| Heartland Research Associates, LLC | Newton | Kansas | 67114 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67205 | United States |
| Best Clinical Trial, LLC | New Orleans | Louisiana | 70115 | United States |
| Peter A. Holt, MD | Baltimore | Maryland | 21239 | United States |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | United States |
| Phase III Clinical Research | Fall River | Massachusetts | 02720 | United States |
| Professional Clinical Research, Inc | Cadillac | Michigan | 49601 | United States |
| Twin Cities Clinical Research | Brooklyn Center | Minnesota | 55430 | United States |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| St. Louis Center for Clinical Research | St Louis | Missouri | 63128 | United States |
| Internal Medical Associates | Grand Island | Nebraska | 68803 | United States |
| South Jersey Medical Associates, PA | Blackwood | New Jersey | 08012 | United States |
| North Carolina Arthritis & Allergy Care Center | Raleigh | North Carolina | 27609 | United States |
| Rapid Medical Research, Inc | Cleveland | Ohio | 44122 | United States |
| Radiant Research | Columbus | Ohio | 43212 | United States |
| Radiant Research, Inc. - Akron | Mogadore | Ohio | 44260 | United States |
| Clinical Research Source, Inc | Perrysburg | Ohio | 43551 | United States |
| Neshaminy Medical, PC | Bensalem | Pennsylvania | 19020 | United States |
| Westminster Family Medicine | Erie | Pennsylvania | 16506 | United States |
| Feasterville Family Health Care Center | Feasterville | Pennsylvania | 19053 | United States |
| Southeastern Pennsylvania Medical Institute | Havertown | Pennsylvania | 19083 | United States |
| Radiant Research | Philadelphia | Pennsylvania | 19115 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Radiant Research - Anderson | Anderson | South Carolina | 29621 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Amarillo Center for Clinical Research | Amarillo | Texas | 79124 | United States |
| Walter F. Chase, M.D., P.A. | Austin | Texas | 78705 | United States |
| Radiant Research Dallas North | Dallas | Texas | 75231 | United States |
| Quality Research, Inc. | San Antonio | Texas | 78209 | United States |
| Radiant Research - San Antonio | San Antonio | Texas | 78229 | United States |
| Texas Research Center, LLP | Sugar Land | Texas | 77479 | United States |
| Health Research of Hampton Roads, Inc. | Newport News | Virginia | 23606 | United States |
| Tidewater Integrated Medical Research | Virginia Beach | Virginia | 23451 | United States |
| The Physicians Clinic of Spokane | Spokane | Washington | 99204 | United States |
| Advanced Healthcare | Milwaukee | Wisconsin | 53209 | United States |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007592 | Joint Diseases |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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