Back to resultsLesinurad and Allopurinol Combination Extension Study in Gout
Primary Purpose
Gout
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lesinurad
Lesinurad
Sponsored by
About this trial
This is an interventional treatment trial for Gout focused on measuring Gout
Eligibility Criteria
Inclusion Criteria:
- Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
- Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit.
- Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth
Exclusion Criteria:
- Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
lesinurad 200 mg + allopurinol
lesinurad 400 mg + allopurinol
Arm Description
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015.
Outcomes
Primary Outcome Measures
Proportion of subjects with an sUA level that is < 6.0 mg/dL
Secondary Outcome Measures
Resolution of at least 1 target tophi
Full Information
NCT ID
NCT01808131
First Posted
March 7, 2013
Last Updated
January 23, 2017
Sponsor
Ardea Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01808131
Brief Title
Lesinurad and Allopurinol Combination Extension Study in Gout
Official Title
A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardea Biosciences, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.
Detailed Description
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with allopurinol in subjects who completed the double-blind treatment period in Studies RDEA594-301 and RDEA594-302.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
Keywords
Gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
717 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lesinurad 200 mg + allopurinol
Arm Type
Experimental
Arm Title
lesinurad 400 mg + allopurinol
Arm Type
Experimental
Arm Description
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015.
Intervention Type
Drug
Intervention Name(s)
Lesinurad
Intervention Description
Tablets, 200 mg QD
Intervention Type
Drug
Intervention Name(s)
Lesinurad
Intervention Description
Tablets, 400 mg QD
Primary Outcome Measure Information:
Title
Proportion of subjects with an sUA level that is < 6.0 mg/dL
Time Frame
up to a total of 5 years
Secondary Outcome Measure Information:
Title
Resolution of at least 1 target tophi
Time Frame
Up to Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit.
Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth
Exclusion Criteria:
Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nihar Bhakta, MD
Organizational Affiliation
Ardea Biosciences, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
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Alabama
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35213
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United States
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Birmingham
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Alabama
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35235
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United States
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Birmingham
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Alabama
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35294
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United States
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Gulf Shores
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36542
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85203
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Peoria
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85381
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Little Rock
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72206
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Little Rock
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72211
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Little Rock
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72223
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92805
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Gold River
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95670
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Denver
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Colorado
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Miami
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Miami
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33027
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29732
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Spartanburg
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South Carolina
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29303
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Union
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Knoxville
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37919
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United States
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Knoxville
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Memphis
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Spring Hill
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Austin
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Dallas
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Houston
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Houston
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Houston
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Richmond
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53226
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4029
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Australia
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Victoria
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3168
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Australia
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Heidelberg West
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Victoria
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3081
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Australia
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Brisbane
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Australia
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Woodville South
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5011
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Australia
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Genk
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3600
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8500
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Belgium
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3920
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5530
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V2A 5C8
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Ontario
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Canada
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London
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Ontario
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Canada
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Ontario
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Quebec
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Bayern
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85072
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Germany
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Goch
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Nordrhein-Westfalen
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47574
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Germany
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Dresden
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Sachsen
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01069
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Germany
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Dresden
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Sachsen
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01307
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Germany
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Kamenz
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Sachsen
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01917
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Germany
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Leipzig
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Sachsen
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04109
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Germany
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Grafton
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Auckland
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1023
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New Zealand
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Otahuhu
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Auckland
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2025
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New Zealand
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Beckenham
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Christchurch
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8024
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New Zealand
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Birkinhead
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0626
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New Zealand
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Hamilton
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3204
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New Zealand
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Rotorua
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3010
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New Zealand
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Tauranga
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3143
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New Zealand
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Krakow
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Malopolskie
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30-510
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Poland
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Slaskie
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40-954
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Poland
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Konskie
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Swietokrzyskie
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26-200
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Poland
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Poznan
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60-773
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82-300
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01-192
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Newlands
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Durban
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City
Silverglen
State/Province
Durban
ZIP/Postal Code
4092
Country
South Africa
City
Newtown
State/Province
Johannesburg
ZIP/Postal Code
2113
Country
South Africa
City
Parktown
State/Province
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
City
Radiokop
State/Province
Johannesburg
ZIP/Postal Code
1724
Country
South Africa
City
Sowento
State/Province
Johannesburg
ZIP/Postal Code
1804
Country
South Africa
City
Thabazimbi
State/Province
Limpopo
ZIP/Postal Code
0380
Country
South Africa
City
Muckleneuk
State/Province
Pretoria
ZIP/Postal Code
0002
Country
South Africa
City
Durban
ZIP/Postal Code
4001
Country
South Africa
City
Paarl
ZIP/Postal Code
7646
Country
South Africa
City
Rondebosch
ZIP/Postal Code
7700
Country
South Africa
City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
City
Witbank
ZIP/Postal Code
1035
Country
South Africa
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
City
Merida
State/Province
Badajoz
ZIP/Postal Code
06800
Country
Spain
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
CH-1011
Country
Switzerland
City
Kharkiv
ZIP/Postal Code
61157
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
City
Kyiv
ZIP/Postal Code
01680
Country
Ukraine
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
Lesinurad and Allopurinol Combination Extension Study in Gout
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