NCT01927198

RDEA3170 Monotherapy in Subjects With Gout

A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RDEA3170 Monotherapy in Subjects With Gout

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	RDEA3170 5 mg
DRUG	RDEA3170 10 mg
DRUG	RDEA3170 12.5 mg

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-05-01
• Completion: 2014-07-01
• First posted: 2013-08-22
• Last updated: 2015-07-01

Locations

49 sites across 1 country: United States