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This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period 2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of allopurinol on tranilast PK and PD as measured by reduction in serum uric acid levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranilast | Experimental | Tranilast tablets |
|
| Allopurinol | Active Comparator | Allopurinol tablets |
|
| Combination | Experimental | Tranilast plus Allopurinol |
|
| High dose Allopurinol | Active Comparator | 400 mg Allopurinol |
|
| High dose combination | Experimental | Combination of Tranilast 300 mg and Allopurinol 400 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranilast | Drug | Tranilast tablets, 300 mg, QD |
| |
| Allopurinol |
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent decrease in serum uric acid levels | Seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination | Seven days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director, Nuon Clinical Trials Group | Nuon Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuon Investigative Site | Honolulu | Hawaii | United States | |||
| Nuon Investigative Site |
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| Drug |
Allopurinol tablets 300 mg, QD |
|
| Combination - Tranilast and Allopurinol | Drug | Tranilast, 300 mg QD; Allopurinol 300 mg QD |
|
| 400 mg Allopurinol | Drug | 400 mg Allopurinol administered once daily for 7 days |
|
| High dose combination | Drug | Combination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days |
|
| Evansville |
| Indiana |
| United States |
| Nuon Investigative Site | Dallas | Texas | United States |
| ID | Term |
|---|---|
| D006073 | Gout |
| 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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| ID | Term |
|---|---|
| C012293 | tranilast |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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