Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
Primary Purpose
Gout and Hyperuricemia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
RDEA3170
Allopurinol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gout and Hyperuricemia
Eligibility Criteria
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
Sites / Locations
- Research Site
- Research Site
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- Research Site
- Research Site
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- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Other
Arm Label
RDEA3170 1
RDEA3170 2
RDEA3170 3
RDEA3170 4
Allopurinol
Arm Description
RDEA3170 5mg followed by RDEA3170 7.5mg
RDEA3170 10mg followed by RDEA3170 12.5mg
RDEA3170 12.5mg followed by RDEA3170 15mg
RDEA3170 Placebo
Allopurinol 200mg
Outcomes
Primary Outcome Measures
Percent Changes of Serum Uric Acid Levels From Baseline Levels
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 Outcome Measures
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
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
Percent Change in sUA
To compare percent change in sUA at each study visit.
Absolute Change of Serum Uric Acid Levels From Baseline Levels
To compare the absolute change of serum uric acid levels from baseline levels
Full Information
NCT ID
NCT02078219
First Posted
February 26, 2014
Last Updated
August 21, 2019
Sponsor
AstraZeneca
Collaborators
Ardea Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02078219
Brief Title
Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 5, 2014 (Actual)
Primary Completion Date
March 13, 2015 (Actual)
Study Completion Date
March 13, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Ardea Biosciences, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout and Hyperuricemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RDEA3170 1
Arm Type
Experimental
Arm Description
RDEA3170 5mg followed by RDEA3170 7.5mg
Arm Title
RDEA3170 2
Arm Type
Experimental
Arm Description
RDEA3170 10mg followed by RDEA3170 12.5mg
Arm Title
RDEA3170 3
Arm Type
Experimental
Arm Description
RDEA3170 12.5mg followed by RDEA3170 15mg
Arm Title
RDEA3170 4
Arm Type
Placebo Comparator
Arm Description
RDEA3170 Placebo
Arm Title
Allopurinol
Arm Type
Other
Arm Description
Allopurinol 200mg
Intervention Type
Drug
Intervention Name(s)
RDEA3170
Intervention Description
Oral Treatment
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Other Intervention Name(s)
Allopurinol 200mg Sawai
Intervention Description
Oral Treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Treatment
Primary Outcome Measure Information:
Title
Percent Changes of Serum Uric Acid Levels From Baseline Levels
Description
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.
Time Frame
Baseline and Week 16
Secondary Outcome Measure Information:
Title
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Description
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
Time Frame
Weeks 1,2,4,6,8,10,12,16,18,20,24
Title
Percent Change in sUA
Description
To compare percent change in sUA at each study visit.
Time Frame
Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
Title
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Description
To compare the 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Research Site
City
Chofu-shi
ZIP/Postal Code
182-0006
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
812-0027
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
819-0006
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
819-8551
Country
Japan
Facility Name
Research Site
City
Kitakyushu-shi
ZIP/Postal Code
807-0857
Country
Japan
Facility Name
Research Site
City
Matsudo-shi
ZIP/Postal Code
270-0021
Country
Japan
Facility Name
Research Site
City
Noda-shi
ZIP/Postal Code
278-8501
Country
Japan
Facility Name
Research Site
City
Ota-ku
ZIP/Postal Code
144-0034
Country
Japan
Facility Name
Research Site
City
Saitama-shi
ZIP/Postal Code
339-8521
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-0011
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
981-0923
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
983-0039
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
983-0835
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
ZIP/Postal Code
141-6003
Country
Japan
12. IPD Sharing Statement
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Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
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