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This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac topical sodium gel 1% | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| OA pain intensity in target hand at Week 4 and 6 | ||
| Total AUSCAN score in target hand at Week 4 and 6 | ||
| Global rating of disease activity by patient at Week 4 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8 | ||
| AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8 |
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Key Inclusion criteria:
• Osteoarthritis of the hand
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35235 | United States | ||
| MedSearch, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20064249 | Derived | Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther. 2010;12(1):R7. doi: 10.1186/ar2906. Epub 2010 Jan 11. | |
| 19648310 | Derived | Altman RD, Dreiser RL, Fisher CL, Chase WF, Dreher DS, Zacher J. Diclofenac sodium gel in patients with primary hand osteoarthritis: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2009 Sep;36(9):1991-9. doi: 10.3899/jrheum.081316. Epub 2009 Jul 31. |
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| OA pain intensity in target hand and use of rescue medication recorded in diary |
| Global evaluation of treatment at final visit |
| Treatment responder rate according to OARSI criteria |
| Calera |
| Alabama |
| 35040 |
| United States |
| Montgomery Rheumatology Associates | Montgomery | Alabama | 36111 | United States |
| Drug Research & Analysis Corp | Montgomery | Alabama | 36124 | United States |
| Arizona Center for Clinical Research | Glendale | Arizona | 85306 | United States |
| Quality of Life Medical Research Center, LLC | Tucson | Arizona | 85712 | United States |
| Lovelace Scientific Resources, Inc. | Beverly Hills | California | 90211 | United States |
| Med Investigations/Med Center | Carmichael | California | 95608 | United States |
| H. Richard Barthel,MD, Inc. | Santa Barbara | California | 93105 | United States |
| Clinical Research of CT/NY | Danbury | Connecticut | 06810 | United States |
| Allergy and Arthritis Associates | Hamden | Connecticut | 06518 | United States |
| Arthritis & Osteoporosis Center, PC | Hamden | Connecticut | 06518 | United States |
| Clinical Research Consultants | Stratford | Connecticut | 06615 | United States |
| Health Core | Newark | Delaware | 19713 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| The Community Research of South Florida | Hialeah | Florida | 33013 | United States |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | United States |
| Miami Research Associates | Miami | Florida | 33173 | United States |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | United States |
| Arthritis Research of Florida, Inc. | Palm Harbor | Florida | 34684 | United States |
| University Clinical Research, Inc. | Pembroke Pines | Florida | 33024 | United States |
| Andres Patron, DO PA | Pembroke Pines | Florida | 33028 | United States |
| Coastal Medical Research | Port Orange | Florida | 32127 | United States |
| University Neurology | Sarasota | Florida | 34243 | United States |
| Southwest Florida Clinical Research Center | Tampa | Florida | 33609 | United States |
| Radiant Research - Atlanta West | Atlanta | Georgia | 30308 | United States |
| Intermountain Orthopaedics | Boise | Idaho | 83702 | United States |
| Allan B. Aven, MD, SC | Arlington Heights | Illinois | 60005 | United States |
| Heartland Research Associates, LLC | Arkansas City | Kansas | 67005 | United States |
| Chesapeake Medical Research, LLC | Baltimore | Maryland | 21239 | United States |
| Arthritis Associates, Inc. | Peabody | Massachusetts | 01960 | United States |
| Clinsite | Ann Arbor | Michigan | 48106 | United States |
| Twin Cities Clinical Research | Brooklyn Center | Minnesota | 55430 | United States |
| Radiant Research - Minneapolis | Edina | Minnesota | 55435 | United States |
| PrimeCare Research Associates | Florissant | Missouri | 63031 | United States |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | United States |
| Comprehensive Clinical Research | Turnersville | New Jersey | 08012 | United States |
| Unifour Medical Research Associates | Hickory | North Carolina | 28601 | United States |
| Crescent Medical Research | Salisbury | North Carolina | 28144 | United States |
| Carolina Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Wells Institute for Heatlh Awareness | Kettering | Ohio | 45429 | United States |
| Clinical Research Source | Perrysburg | Ohio | 43551 | United States |
| PRO Research | Eugene | Oregon | 97401 | United States |
| Allegheny Pain Management | Altoona | Pennsylvania | 16602 | United States |
| Neshaminy Medical, PC | Bensalem | Pennsylvania | 19020 | United States |
| Medical Group @ Marple Commons | Broomall | Pennsylvania | 19008 | 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 |
| Radiant Research - Reading | Wyomissing | Pennsylvania | 19610 | United States |
| Partners in Clinical Research | Woonsocket | Rhode Island | 02895 | United States |
| Radiant Research - Anderson | Anderson | South Carolina | 29621 | United States |
| Palmetto Medical Research | Mt. Pleasant | South Carolina | 29464 | United States |
| Harmony Research, Inc. | Johnson City | Tennessee | 37601 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Amarillo Center for Clinical Research | Amarillo | Texas | 79124 | United States |
| Walter F. Chase, MD, PA | Austin | Texas | 78705 | United States |
| Quality Research, Inc. | San Antonio | Texas | 78209 | United States |
| Radiant Research - San Antonio Northeast | San Antonio | Texas | 78217 | United States |
| Radiant Research - San Antonio | San Antonio | Texas | 78229 | United States |
| Texas Research Center, LLP | Sugar Land | Texas | 77479 | United States |
| Intermoutain Clinical Research | Salt Lake City | Utah | 84102 | United States |
| Radiant Research - Salt Lake City | Salt Lake City | Utah | 84107 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Health Research of Hampton Roads, Inc. | Newport News | Virginia | 23606 | United States |
| Radiant Research - Tacoma | Lakewood | Washington | 98499 | United States |
| Advanced Healthcare, SC | Milwaukee | Wisconsin | 53209 | United States |
| Dean Medical Center - Oregon Clinic | Oregon | Wisconsin | 53575 | United States |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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