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This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | AR882 Dose 1 x 12 weeks |
|
| Group 2 | Experimental | AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks |
|
| Group 3 | Placebo Comparator | AR882 matching placebo x 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR882 Dose 1 | Drug | Solid Oral Capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| sUA levels < 5, < 4, and < 3 mg/dL | Comparison of the treatment groups for proportion of patients whose sUA levels are < 5, < 4, and < 3 mg/dL | 6 weeks |
| Incidence of Adverse Events | Treatment Emergent Adverse Events and Serious Adverse Event incidence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R Keenan, MD | Arthrosi Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthrosi Investigative Site | Gilbert | Arizona | 85297 | United States | ||
| Arthrosi Investigative Site |
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| AR882 Dose 2 |
| Drug |
Solid Oral Capsule |
|
| Placebo | Drug | Matching Solid Oral Capsule Placebo |
|
| 14 weeks |
| Maximum Observed Plasma Concentration (Cmax) | Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax. | 12 weeks |
| Time to observed Cmax (Tmax) | Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax. | 12 weeks |
| Area under the plasma concentration-time curve (AUC) | Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive AUC. | 12 weeks |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Arthrosi Investigative Site | Tucson | Arizona | 85704 | United States |
| Arthrosi Investigative Site | Miami | Florida | 33143 | United States |
| Arthrosi Investigative Site | Miami Lakes | Florida | 33014 | United States |
| Arthrosi Investigative Site | Tampa | Florida | 33613 | United States |
| Arthrosi Investigative Site | Honolulu | Hawaii | 96814 | United States |
| Arthrosi Investigative Site | Overland Park | Kansas | 66212 | United States |
| Arthrosi Investigative Site | Cleveland | Ohio | 44122 | United States |
| Arthrosi Investigative Site | Cleveland | Ohio | 44195 | United States |
| Arthrosi Investigative Site | Duncansville | Pennsylvania | 16635 | United States |
| Arthrosi Investigative Site | Dallas | Texas | 75231 | United States |
| Arthrosi Investigative Site | Houston | Texas | 77074 | United States |
| Arthrosi Investigative Site | Tomball | Texas | 77375 | United States |
| Arthrosi Investigative Site | West Jordan | Utah | 84088 | United States |
| Arthrosi Investigative Site | Glendale | Wisconsin | 53217 | United States |
| Arthrosi Investigative Site | Melbourne | Camberwell | 3124 | Australia |
| Arthrosi investigative Site | Botany | New South Wales | 2019 | Australia |
| Arthrosi Investigative Site | Taichung | 402 | Taiwan |
| Arthrosi Investigative Site - 301 | Taipei | 112 | Taiwan |
| Arthrosi Investigative Site - 304 | Taipei | 112 | Taiwan |
| Arthrosi Investigative Site | Taipei | 114 | Taiwan |
| Arthrosi Investigative Site | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D006073 | Gout |
| D015210 | Arthritis, Gouty |
| D033461 | Hyperuricemia |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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