RDEA3170 Monotherapy in Subjects With Gout
This study will assess the serum uric acid lowering effects and safety of 3 dose levels of RDEA3170 compared to placebo in subjects with gout.
Drug: RDEA3170 5 mg
Drug: RDEA3170 10 mg
Drug: RDEA3170 12.5 mg
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RDEA3170 Monotherapy in Subjects With Gout|
- Efficacy of RDEA3170 monotherapy at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Percent change from baseline in serum urate levels at Week 12.
- Incidence of treatment-emergent adverse events and change from baseline in laboratory values, vital signs, and electrocardiograms [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]Safety assessments include adverse event (AE) recording, gout flare recording, clinical safety laboratory tests (eg, hematology, serum chemistry, and urinalysis), physical examinations, vital sign measurements, and ECGs.
- Efficacy of RDEA3170 monotherapy at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]Percent change from baseline in serum urate levels at each visit. Proportion of subjects with a serum urate level < 6.0 and < 5.0 mg/dL at each visit.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||July 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: RDEA3170 5 mg qd
|Drug: RDEA3170 5 mg|
Experimental: RDEA3170 10 mg qd
Increase from RDEA3170 5 mg to RDEA3170 10 mg qd at Week 2.
|Drug: RDEA3170 10 mg|
Experimental: RDEA3170 12.5 mg qd
Increase from RDEA3170 10 mg to RDEA3170 12.5 mg qd at Week 4.
|Drug: RDEA3170 12.5 mg|
Placebo Comparator: Placebo
This monotherapy study is the initial Phase 2 study for RDEA3170 and is designed to compare the safety and efficacy of multiple dose levels of RDEA3170 with placebo when given for up to 24 weeks to subjects with gout. The placebo control for RDEA3170 is included in this study to minimize bias in study assessments and monitoring. Further, to accomplish the goal of understanding the safety profile of RDEA3170, it is important to compare RDEA3170 monotherapy with placebo for at least 24 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01927198
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|Study Director:||J. Hall, MD||Ardea Biosciences, Inc.|