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| Name | Class |
|---|---|
| Gedeon Richter Ltd. | INDUSTRY |
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This study is designed to evaluate the safety and efficacy of RGH-896 in patients with diabetic peripheral neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Active Comparator |
| |
| 5 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGH-896 | Drug | 45 mg TID, capsules, 14 weeks. |
| |
| RGH-896 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean daily pain rating | Baseline to Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 50% reduction in pain | Baseline to Week 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allyson Gage, PhD | Forest Research Institute, a subsidiary of Forest Laboratories Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site | Birmingham | Alabama | 35242 | United States | ||
| Forest Investigative Site |
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| Drug |
30 mg TID, capsules, 14 weeks. |
|
| RGH-896 | Drug | 15 mg TID, capsules, 14 weeks. |
|
| pregabalin | Drug | 100 mg, TID, capsules, 14 weeks. |
|
|
| placebo | Drug | TID, capsules, 14 weeks. |
|
| Mesa |
| Arizona |
| 85210 |
| United States |
| Forest Investigative Site | Tempe | Arizona | 85282 | United States |
| Forest Investigative Site | Jonesboro | Arkansas | 72401 | United States |
| Forest Investigative Site | Little Rock | Arkansas | 72205 | United States |
| Forest Investigative Site | North Little Rock | Arkansas | 72114 | United States |
| Forest Investigative Site | Anaheim | California | 92801 | United States |
| Forest Investigative Site | Burbank | California | 91505 | United States |
| Forest Investigative Site | Lakewood | California | 90712 | United States |
| Forest Investigative Site | National City | California | 91950 | United States |
| Forest Investigative Site | Riverside | California | 92506 | United States |
| Forest Investigative Site | Sacramento | California | 95821 | United States |
| Forest Investigative Site | San Diego | California | 92117 | United States |
| Forest Investigative Site | Santa Monica | California | 90404 | United States |
| Forest Investigative Site | Tustin | California | 92780 | United States |
| Forest Investigative Site | Walnut Creek | California | 94598 | United States |
| Forest Investigative Site | Westlake Village | California | 91361 | United States |
| Forest Investigative Site | Boulder | Colorado | 80304 | United States |
| Forest Investigative Site | New Britain | Connecticut | 06050 | United States |
| Forest Investigative Site | Bradenton | Florida | 34203 | United States |
| Forest Investigative Site | Brandon | Florida | 33511 | United States |
| Forest Investigative Site | DeLand | Florida | 32720 | United States |
| Forest Investigative Site | Hollywood | Florida | 33023 | United States |
| Forest Investigative Site | Jacksonville | Florida | 32216 | United States |
| Forest Investigative Site | Miami | Florida | 33108 | United States |
| Forest Investigative Site | Orlando | Florida | 32806 | United States |
| Forest Investigative Site | Pembroke Pines | Florida | 33024 | United States |
| Forest Investigative Site | Tampa | Florida | 33606 | United States |
| Forest Investigative Site | West Palm Beach | Florida | 33401 | United States |
| Forest Investigative Site | Honolulu | Hawaii | 96814 | United States |
| Forest Investigative Site | Boise | Idaho | 83642 | United States |
| Forest Investigative Site | Wichita | Kansas | 67203 | United States |
| Forest Investigative Site | Covington | Louisiana | 70433 | United States |
| Forest Investigative Site | Owings Mills | Maryland | 21117 | United States |
| Forest Investigative Site | St Louis | Missouri | 63141 | United States |
| Forest Investigative Site | West Caldwell | New Jersey | 07006 | United States |
| Forest Investigative Site | Albuquerque | New Mexico | 87108 | United States |
| Forest Investigative Site | New York | New York | 10004 | United States |
| Forest Investigative Site | Charlotte | North Carolina | 28211 | United States |
| Forest Investigative Site | Greenville | North Carolina | 27834 | United States |
| Forest Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Forest Investigative Site | Cleveland | Ohio | 44122 | United States |
| Forest Investigative Site | Kettering | Ohio | 45429 | United States |
| Forest Investigative Site | Tulsa | Oklahoma | 74104 | United States |
| Forest Investigative Site | Duncansville | Pennsylvania | 16635 | United States |
| Forest Investigative Site | Philadelphia | Pennsylvania | 19139 | United States |
| Forest Investigative Site | Columbia | South Carolina | 29201 | United States |
| Forest Investigative Site | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site | Dallas | Texas | 75246 | United States |
| Forest Investigative Site | Lake Jackson | Texas | 77566 | United States |
| Forest Investigative Site | San Antonio | Texas | 78229 | United States |
| Forest Investigative Site | Salt Lake City | Utah | 84106 | United States |
| Forest Investigative Site | Virginia Beach | Virginia | 23454 | United States |
| Forest Investigative Site | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D010146 | Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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