Hyperuricemia, Moderate to Severe Gout
Conditions
Keywords
Moderate to severe gout, Hyperuricemia
Brief summary
This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients with hyperuricemia and moderate to severe gout.
Interventions
DRUGCombination 400
Tranilast 300 mg QD; Allopurinol 400 mg QD
DRUGAllopurinol
Allopurinol 400 mg, QD
DRUGCombination 600
Tranilast, 300 mg QD; Allopurinol 600 mg QD
Sponsors
Nuon Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18 to 80 * Severe gout, demonstrated by 3 or more gout flares in the previous 12 months, or the presence of at least one gout tophus or gouty arthritis * Hyperuricemia with a sUA ≥8.0 mg/dL
Exclusion criteria
* Pregnant or nursing * Known hypersensitivity to any of the components of tranilast or allopurinol * Known history of xanthinuria or kidney stones * Use of an investigational drug within 30 days * Presence of, or history of, cancer with the exception of completely excised, non-metastatic squamous cell and basal cell carcinomas of the skin * Subject is planning or likely to require a surgical procedure during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in serum uric acid (sUA) levels | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing | 4 weeks |
Countries
United States
Outcome results
None listed