GoutPhase 2NCT02246673

RDEA3170 and Febuxostat Combination Study in Gout Subjects

A Phase 2 study testing RDEA3170 15 mg, RDEA3170 10 mg and RDEA3170 2.5 in people with Gout, run by Ardea Biosciences, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to febuxostat administered alone in adult subjects with gout. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gout
What is being tested?: RDEA3170 15 mg, RDEA3170 10 mg and RDEA3170 2.5
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 6 sitesUnited States
Study dates: Oct 2014to Feb 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity.
Meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 45 kg/m2.
Screening serum urate level ≥ 8 mg/dL.
Free of any clinically significant disease or medical condition, per the Investigator's judgment.

Who cannot join

Unable to take colchicine for gout flare prophylaxis.
History or suspicion of kidney stones.
Any gastrointestinal disorder that affects motility and/or absorption.
Unstable angina, New York Heart Association class III or IV heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or subject is currently receiving anticoagulants.
Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.
Estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period.
Taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2 inhibitors; chronic and stable doses are permitted if doses are stable for at least 14 days prior to study medication dosing.
Unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Anaheim, California, 92801
Study site
Dallas, Texas, 75231
Study site
Glendale, California, 91206
Study site
Overland Park, Kansas, 66211
Study site
Overland Park, Kansas, 66212
Study site
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Febuxostat Compared to Febuxostat Administered Alone in Adult Subjects With Gout

Conditions: Gout
Being tested: RDEA3170 15 mg, RDEA3170 10 mg, RDEA3170 2.5, RDEA3170 5 mg, Febuxostat 40 mg
Medical subject headings: Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RDEA3170 15 mgDrug
RDEA3170 10 mgDrug
RDEA3170 2.5Drug
RDEA3170 5 mgDrug
Febuxostat 40 mgDrug
Febuxostat 80 mgDrug

Study groups in NCT02246673
Study group	Role	What they receive
RDEA3170 10 mg	Experimental	Once daily (qd) with febuxostat 40mg (qd) for 7 days, and with febuxostat 80 mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days. Receives: Drug: RDEA3170 10 mg; Drug: Febuxostat 40 mg; Drug: Febuxostat 80 mg
RDEA3170 15 mg	Experimental	Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days. Receives: Drug: RDEA3170 15 mg; Drug: RDEA3170 5 mg; Drug: Febuxostat 40 mg; Drug: Febuxostat 80 mg
RDEA3170 5 mg	Experimental	Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days. Receives: Drug: Febuxostat 40 mg; Drug: Febuxostat 80 mg
RDEA3170 2.5 mg	Experimental	Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days. Receives: Drug: RDEA3170 2.5; Drug: Febuxostat 40 mg; Drug: Febuxostat 80 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Urate Maximum Percentage (%) Change (Emax, CB)
Maximum observed percentage (%) change from baseline in serum urate concentrations.
Measured: 28 days
Urine Uric Acid % Change (0-24h) (Aeur, CB)
Percentage (%) change from baseline in the amount of uric acid recovered in urine.
Measured: 28 days
Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)
Percentage (%) change from baseline in renal clearance of uric acid.
Measured: 28 days
Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)
Percentage (%) change from baseline in fractional excretion of uric acid.
Measured: 28 days

Secondary outcomes (6)

Maximum Observed Plasma Concentration (Cmax)
Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Measured: Days 7 to 28
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Measured: Days 7 to 28
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Measured: Days 7 to 28
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Measured: Days 7 to 28
Apparent Terminal Half-life (t1/2)
t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Measured: Days 7 to 28
Incidence of Treatment-Emergent Adverse Events
Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Feb 2016

First posted23 Sep 2014 (estimated)
Study startOct 2014
Primary completionJul 2015
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for GoutStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02246673
Sponsor's protocol ID: RDEA3170-204
Status last verified: Jun 2017
First submitted: 19 Sep 2014
Last updated: 27 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Rekic D, Johansson S, Leander J. Higher Febuxostat Exposure Observed in Asian Compared with Caucasian Subjects Independent of Bodyweight. Clin Pharmacokinet. 2021 Mar;60(3):319-328. doi: 10.1007/s40262-020-00943-6. Epub 2020 Sep 19.
PubMed 32951150
Fleischmann R, Winkle P, Hall J, Valdez S, Liu S, Yan X, Hicks L, Lee C, Miner JN, Gillen M, Hernandez-Illas M. Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with febuxostat in adults with gout: a phase IIa, open-label study. RMD Open. 2018 Apr 9;4(1):e000647. doi: 10.1136/rmdopen-2018-000647. eCollection 2018.
PubMed 29657831

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy

All Gout trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Febuxostat Compared to Febuxostat Administered Alone in Adult Subjects With Gout
ClinicalTrials.gov ID: NCT02246673
Acronym / sponsor ID: RDEA3170-204
Conditions: Gout
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Jul 2015 (actual)
Study completion: Feb 2016 (actual)
First posted: 23 Sep 2014 (estimated)
Results: Posted 27 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
RDEA3170 10 mg	Experimental	Drug: RDEA3170 10 mg, Drug: Febuxostat 40 mg, Drug: Febuxostat 80 mgOnce daily (qd) with febuxostat 40mg (qd) for 7 days, and with febuxostat 80 mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
RDEA3170 15 mg	Experimental	Drug: RDEA3170 15 mg, Drug: RDEA3170 5 mg, Drug: Febuxostat 40 mg, Drug: Febuxostat 80 mgOnce daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
RDEA3170 5 mg	Experimental	Drug: Febuxostat 40 mg, Drug: Febuxostat 80 mgOnce daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.
RDEA3170 2.5 mg	Experimental	Drug: RDEA3170 2.5, Drug: Febuxostat 40 mg, Drug: Febuxostat 80 mgOnce daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity.
Meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 45 kg/m2.
Screening serum urate level ≥ 8 mg/dL.
Free of any clinically significant disease or medical condition, per the Investigator's judgment.

Key exclusion criteria (8 listed)

Unable to take colchicine for gout flare prophylaxis.
History or suspicion of kidney stones.
Any gastrointestinal disorder that affects motility and/or absorption.
Unstable angina, New York Heart Association class III or IV heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or subject is currently receiving anticoagulants.
Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RDEA3170 15 mg	Drug	RDEA3170 15 mg
RDEA3170 10 mg	Drug	RDEA3170 10 mg
RDEA3170 2.5	Drug	RDEA3170 2.5 mg
RDEA3170 5 mg	Drug	RDEA3170 15 mg
Febuxostat 40 mg	Drug	RDEA3170 10 mg, RDEA3170 15 mg, RDEA3170 2.5 mg, RDEA3170 5 mg
Febuxostat 80 mg	Drug	RDEA3170 10 mg, RDEA3170 15 mg, RDEA3170 2.5 mg, RDEA3170 5 mg

Primary outcome

Serum Urate Maximum Percentage (%) Change (Emax, CB)
Time frame: 28 days
Maximum observed percentage (%) change from baseline in serum urate concentrations.
Urine Uric Acid % Change (0-24h) (Aeur, CB)
Time frame: 28 days
Percentage (%) change from baseline in the amount of uric acid recovered in urine.
Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)
Time frame: 28 days
Percentage (%) change from baseline in renal clearance of uric acid.
Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)
Time frame: 28 days
Percentage (%) change from baseline in fractional excretion of uric acid.

6 secondary outcomes

Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 7 to 28
Time of Occurrence of Maximum Observed Concentration (Tmax)
Time frame: Days 7 to 28
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
Time frame: Days 7 to 28
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
Time frame: Days 7 to 28
Apparent Terminal Half-life (t1/2)
Time frame: Days 7 to 28
Incidence of Treatment-Emergent Adverse Events
Time frame: 10 weeks

Results and safety

Results posted to the registry on 27 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	14	13
Cohort 2	12	12
Cohort 3	12	12
Cohort 4	14	12
Cohort 5	12	11

Primary outcome: Serum Urate Maximum Percentage (%) Change (Emax, CB)

Time frame: 28 days. Mean (Standard Error). Unit: Percentage (%)

Measure	Febuxostat 40 mg n = 58	Febuxostat 80 mg n = 47	RDEA3170 10 mg + Febuxostat 40 mg n = 22	RDEA3170 10 mg + Febuxostat 80 mg n = 10	RDEA3170 15 mg + Febuxostat 40 mg n = 23	RDEA3170 15 mg + Febuxostat 80 mg n = 11	RDEA3170 5 mg + Febuxostat 40 mg n = 12	RDEA3170 5 mg + Febuxostat 80 mg n = 12	RDEA3170 2.5 mg + Febuxostat 40 mg n = 12	RDEA3170 2.5 mg + Febuxostat 80 mg n = 12	RDEA3170 20 mg + Febuxostat 40 mg n = 11
Value	-43.5 (1.10)	-55.6 (1.37)	-70.4 (1.35)	-79.1 (2.53)	-74.9 (1.18)	-82.4 (1.76)	-59.4 (2.81)	-66.7 (2.32)	-52.5 (2.51)	-62.7 (2.69)	-77.3 (1.18)

Febuxostat 40 mg vs RDEA3170 10 mg + Febuxostat 40 mg: Geometric Least Squares mean Ratio: -28.18 (95% CI -33.85 to -22.51), p <0.0001, Mixed Models Analysis
Febuxostat 80 mg vs RDEA3170 10 mg + Febuxostat 80 mg: Geometric Least Squares mean Ratio: -25.29 (95% CI -31.23 to -19.34), p <0.0001, Mixed Models Analysis
Febuxostat 40 mg vs RDEA3170 15 mg + Febuxostat 40 mg: Geometric Least Squares mean Ratio: -29.15 (95% CI -33.15 to -25.15), p <0.0001, Mixed Models Analysis

Primary outcome: Urine Uric Acid % Change (0-24h) (Aeur, CB)

Time frame: 28 days. Mean (Standard Error). Unit: Percentage (%)

Measure	Febuxostat 40 mg n = 56	Febuxostat 80 mg n = 45	RDEA3170 10 mg + Febuxostat 40 mg n = 24	RDEA3170 10 mg + Febuxostat 80 mg n = 13	RDEA3170 15 mg + Febuxostat 40 mg n = 22	RDEA3170 15 mg + Febuxostat 80 mg n = 10	RDEA3170 5 mg + Febuxostat 40 mg n = 10	RDEA3170 5 mg + Febuxostat 80 mg n = 10	RDEA3170 2.5 mg + Febuxostat 40 mg n = 11	RDEA3170 2.5 mg + Febuxostat 80 mg n = 11	RDEA3170 20 mg + Febuxostat 40 mg n = 10
Value	-48.6 (1.71)	-60.3 (1.58)	-23.7 (5.56)	-36.6 (6.75)	-22.9 (4.15)	-44.4 (5.57)	-26.2 (8.28)	-39.2 (5.95)	-40.2 (4.07)	-61.1 (2.16)	-14.2 (10.9)

Febuxostat 40 mg vs RDEA3170 10 mg + Febuxostat 40 mg: Geometric Least Squares mean Ratio: 24.27 (95% CI 12.57 to 35.98), p = 0.0002, Mixed Models Analysis
Febuxostat 80 mg vs RDEA3170 10 mg + Febuxostat 80 mg: Geometric Least Squares mean Ratio: 20.08 (95% CI 8.38 to 31.79), p = 0.0013, Mixed Models Analysis
Febuxostat 40 mg vs RDEA3170 15 mg + Febuxostat 40 mg: Geometric Least Squares mean Ratio: 23.70 (95% CI 14.23 to 33.17), p <0.0001, Mixed Models Analysis

Primary outcome: Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)

Time frame: 28 days. Mean (Standard Error). Unit: Percentage (%)

Measure	Febuxostat 40 mg n = 50	Febuxostat 80 mg n = 37	RDEA3170 10 mg + Febuxostat 40 mg n = 21	RDEA3170 10 mg + Febuxostat 80 mg n = 10	RDEA3170 15 mg + Febuxostat 40 mg n = 20	RDEA3170 15 mg + Febuxostat 80 mg n = 10	RDEA3170 5 mg + Febuxostat 40 mg n = 10	RDEA3170 5 mg + Febuxostat 80 mg n = 10	RDEA3170 2.5 mg + Febuxostat 40 mg n = 10	RDEA3170 2.5 mg + Febuxostat 80 mg n = 10	RDEA3170 20 mg + Febuxostat 40 mg n = 9
Value	-15.2 (2.53)	-18.8 (2.52)	125 (17.4)	153 (30.5)	157 (15.9)	172 (30.0)	58.7 (15.7)	68.4 (24.7)	20.9 (10.1)	0.011 (7.36)	223 (47.0)

Febuxostat 40 mg vs RDEA3170 10 mg + Febuxostat 40 mg: Geometric Least Squares mean Ratio: 139.11 (95% CI 93.92 to 184.31), p <0.0001, Mixed Models Analysis
Febuxostat 80 mg vs RDEA3170 10 mg + Febuxostat 80 mg: Geometric Least Squares mean Ratio: 174.47 (95% CI 125.52 to 233.42), p <0.0001, Mixed Models Analysis
Febuxostat 40 mg vs RDEA3170 15 mg + Febuxostat 40 mg: Geometric Least Squares mean Ratio: 168.03 (95% CI 123.13 to 212.93), p <0.0001, Mixed Models Analysis

Primary outcome: Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)

Time frame: 28 days. Mean (Standard Error). Unit: Percentage (%)

Measure	Febuxostat 40 mg n = 47	Febuxostat 80 mg n = 33	RDEA3170 10 mg + Febuxostat 40 mg n = 21	RDEA3170 10 mg + Febuxostat 80 mg n = 8	RDEA3170 15 mg + Febuxostat 40 mg n = 19	RDEA3170 15 mg + Febuxostat 80 mg n = 10	RDEA3170 5 mg + Febuxostat 40 mg n = 7	RDEA3170 5 mg + Febuxostat 80 mg n = 7	RDEA3170 2.5 mg + Febuxostat 40 mg n = 10	RDEA3170 2.5 mg + Febuxostat 80 mg n = 10	RDEA3170 20 mg + Febuxostat 40 mg n = 9
Value	-20.6 (1.82)	-20.8 (2.62)	100 (13.4)	155 (32.4)	133 (12.2)	152 (26.2)	46.6 (9.36)	54.8 (20.5)	15.2 (9.30)	4.73 (6.15)	162 (23.2)

Febuxostat 40 mg vs RDEA3170 10 mg + Febuxostat 40 mg: Geometric Least Squares mean Ratio: 135.82 (95% CI 93.33 to 178.32), p <0.0001, Mixed Models Analysis
Febuxostat 80 mg vs RDEA3170 10 mg + Febuxostat 80 mg: Geometric Least Squares mean Ratio: 178.58 (95% CI 129.25 to 227.90), p <0.0001, Mixed Models Analysis
Febuxostat 40 mg vs RDEA3170 15 mg + Febuxostat 40 mg: Geometric Least Squares mean Ratio: 163.98 (95% CI 120.80 to 207.16), p <0.0001, Mixed Models Analysis

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Febuxostat 40 mg	0 of 61 (0%)	3 of 61 (4.9%)	Not reported
Febuxostat 80 mg	0 of 51 (0%)	8 of 51 (15.7%)	Not reported
Overall RDEA3170 + Febuxostat Combination	0 of 62 (0%)	13 of 62 (21%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32951150Rekic D, Johansson S, Leander J. Higher Febuxostat Exposure Observed in Asian Compared with Caucasian Subjects Independent of Bodyweight. Clin Pharmacokinet. 2021 Mar;60(3):319-328. doi: 10.1007/s40262-020-00943-6. Epub 2020 Sep 19.
Derived from this study: PubMed 29657831Fleischmann R, Winkle P, Hall J, Valdez S, Liu S, Yan X, Hicks L, Lee C, Miner JN, Gillen M, Hernandez-Illas M. Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with febuxostat in adults with gout: a phase IIa, open-label study. RMD Open. 2018 Apr 9;4(1):e000647. doi: 10.1136/rmdopen-2018-000647. eCollection 2018.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

J. Hall study director

Ardea Biosciences, Inc.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RDEA3170 15 mg, RDEA3170 10 mg and RDEA3170 2.5 in people with Gout, run by Ardea Biosciences, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Urate Maximum Percentage (%) Change (Emax, CB) (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02246673, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.