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Completed

NCT Number: NCT02078219

Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia

This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in greater reduction of sUA compared to placebo.

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Key information

Conditions

Gout and Hyperuricemia Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Hyperuricemia Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Chofu-shi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject meets any of the following criteria and with sUA ≤10.0 mg/dL:
  • sUA level of >7.0 mg/dL at 7 days prior to baseline with gout;
  • sUA level of ≥8.0 mg/dL at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabetes, metabolic syndrome);
  • sUA level of ≥9.0 mg/dL at 7 days prior to baseline without gout and complications.

Exclusion criteria

  • Subject with an acute gout flare that has not resolved at least 14 days prior to the baseline visit.
  • Subject has a history or suspicion of kidney stones.
  • Subject has an estimated creatinine clearance <60 mL/min calculated by the Cockcroft Gault formula
  • Subject is receiving strong or moderate CYP3A inhibitors

Treatment and study plan

RDEA3170

Drug

Oral Treatment

Allopurinol

Drug

Oral Treatment

Other names: Allopurinol 200mg Sawai

Placebo

Drug

Oral Treatment

Primary outcomes

  1. Percent Changes of Serum Uric Acid Levels From Baseline Levels

    Time frame: Baseline and Week 16

    The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.

Secondary outcomes

  1. Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL

    Time frame: Weeks 1,2,4,6,8,10,12,16,18,20,24

    To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit

  2. Percent Change in sUA

    Time frame: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24

    To compare percent change in sUA at each study visit.

  3. Absolute Change of Serum Uric Acid Levels From Baseline Levels

    Time frame: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24

    To compare the absolute change of serum uric acid levels from baseline levels

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Ardea Biosciences, Inc.

Registry information

Official study title

A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, 24-Week Phase II Study to Evaluate Efficacy and Safety of RDEA3170 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg Versus Placebo and Open-Label Allopurinol 200 mg as a Reference Arm in Japanese Patients With Gout or Asymptomatic Hyperuricemia

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2014
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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