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D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol |
|
| Cohort B | Experimental | week 1: D-0120 low dose in combination with Allopurinol week 2: D-0120 increased dose in combination with Allopurinol week 3-12: D-0120 high dose in combination with Allopurinol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-0120 | Drug | increasing dose of D-0120 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| • To assess the efficacy of D-0120 in combination with allopurinol to reduce serum urate levels in treatment of patients with gout by week 12 | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Stazzone | InventisBio Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Center | Birmingham | Alabama | 35233 | United States | ||
| Site Center |
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Randomized , Open Label, Multiple Dose
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| Allopurinol |
| Drug |
standard dosing |
|
| Plantation |
| Florida |
| 33324 |
| United States |
| Study Center | Evergreen Park | Illinois | 60805 | United States |
| Study Center | Brownsburg | Indiana | 46254 | United States |
| Site Center | Louisville | Kentucky | 40205 | United States |
| Study Center | Hickory | North Carolina | 28601 | United States |
| Study Center | Rocky Mount | North Carolina | 27804 | United States |
| Study Center | Salisbury | North Carolina | 28144 | United States |
| Study Center | Wilmington | North Carolina | 28401 | United States |
| Study Center | Winston-Salem | North Carolina | 27103 | United States |
| Study Center | Scottdale | Pennsylvania | 15683 | United States |
| Study Center | Bristol | Tennessee | 37620 | United States |
| Site Center | Hendersonville | Tennessee | 37075 | United States |
| Study Center | Knoxville | Tennessee | 37909 | United States |
| Site Center | Fort Worth | Texas | 76109 | United States |
| Site Center | The Woodlands | Texas | 77382 | United States |
| Site Center | Richmond | Virginia | 23219 | United States |
| Site Center | Bellevue | Washington | 98004 | United States |
| Study Center | Morgantown | West Virginia | 26505 | United States |
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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