GoutPhase 2NCT02498652

Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects

A Phase 2 study testing RDEA3170 2.5 mg and allopurinol 300 mg in people with Gout, run by Ardea Biosciences, Inc. at 4 sites in United States.

Completed

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

Official record

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Trial summary

This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects of RDEA3170 administered in combination with allopurinol compared with allopurinol 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 2.5 mg and allopurinol 300 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 4 sitesUnited States
Study dates: 28 Jul 2015to 2 Jun 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

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 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.
Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m2.
Subject has a Screening serum urate level ≥ 8 mg/dL.
Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Who cannot join

Subject is unable to take colchicine for gout flare prophylaxis.
Subject has a history or suspicion of kidney stones.
Subject has any gastrointestinal disorder that affects motility and/or absorption.
Subject had 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.
Subject has Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.
Subject has an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period.
Subject is 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.
Subject is 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

4 sites in 1 country.

United States4 sites

Study site
Anaheim, California, 92801
Study site
Dallas, Texas, 75231
Study site
DeLand, Florida, 32720
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 Allopurinol Compared With Allopurinol Administered Alone in Adult Subjects With Gout

Conditions: Gout
Being tested: RDEA3170 2.5 mg, allopurinol 300 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 2.5 mgDrug
Cohort 1: RDEA3170 2.5 mg, 7.5 mg (2.5 mg × 3 tablets), and 15 mg (2.5 mg × 6 tablets).
Cohort 2: RDEA3170 5 mg (2.5 mg × 2 tablets), 10 mg (2.5 mg × 4 tablets), and 20 mg (2.5 mg × 8 tablets).
allopurinol 300 mgDrug
allopurinol 300 mg, allopurinol 600 mg (300 mg x 2 tablets)

Study groups in NCT02498652
Study group	Role	What they receive
RDEA3170 2.5 mg, 7.5 mg and 15 mg	Experimental	RDEA3170 2.5 mg, 7.5 mg and 15 mg once daily (qd) in combination with allopurinol 300 mg (qd and twice daily (bid)) Receives: Drug: RDEA3170 2.5 mg; Drug: allopurinol 300 mg
RDEA3170 5 mg, 10 mg and 20 mg	Experimental	RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid) Receives: Drug: RDEA3170 2.5 mg; Drug: allopurinol 300 mg

What is being measured

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

Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Measured: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Measured: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Measured: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Measured: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Measured: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Measured: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Measured: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Measured: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)

Secondary outcomes (6)

Maximum Observed Concentration (Cmax)
Cmax of Allopurinol alone or in combination with RDEA3170
Measured: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax of Allopurinol alone or in combination with RDEA3170
Measured: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
AUC 0-24 of Allopurinol alone or in combination with RDEA3170
Measured: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
AUC last of Allopurinol alone or in combination with RDEA3170
Measured: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Apparent Terminal Half-life (t1/2)
t1/2 of Allopurinol alone or in combination with RDEA3170
Measured: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Number of Participants With Treatment-Emergent Adverse Events
Measured: 11 weeks

Timeline

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

28 Jul 20152 Jun 2016

First posted15 Jul 2015 (estimated)
Study start28 Jul 2015
Primary completion19 Nov 2015
Study completion2 Jun 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 (1)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: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02498652
Sponsor's protocol ID: RDEA3170-206
Status last verified: Dec 2017
First submitted: 13 Jul 2015
Last updated: 23 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fleischmann R, Winkle P, Miner JN, Yan X, Hicks L, Valdez S, Hall J, Liu S, Shen Z, Gillen M, Hernandez-Illas M. Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with allopurinol in adults with gout: a phase IIa, open-label study. RMD Open. 2018 Feb 8;4(1):e000584. doi: 10.1136/rmdopen-2017-000584. eCollection 2018.
PubMed 29531784

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

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All Gout trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2018. 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 Allopurinol Compared With Allopurinol Administered Alone in Adult Subjects With Gout
ClinicalTrials.gov ID: NCT02498652
Acronym / sponsor ID: RDEA3170-206
Conditions: Gout
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: 28 Jul 2015 (actual)
Primary completion: 19 Nov 2015 (actual)
Study completion: 2 Jun 2016 (actual)
First posted: 15 Jul 2015 (estimated)
Results: Posted 23 Jan 2018

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: 2

Arm	Type	Receives
RDEA3170 2.5 mg, 7.5 mg and 15 mg	Experimental	Drug: RDEA3170 2.5 mg, Drug: allopurinol 300 mgRDEA3170 2.5 mg, 7.5 mg and 15 mg once daily (qd) in combination with allopurinol 300 mg (qd and twice daily (bid))
RDEA3170 5 mg, 10 mg and 20 mg	Experimental	Drug: RDEA3170 2.5 mg, Drug: allopurinol 300 mgRDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)

Who may qualify

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

Key inclusion criteria (5 listed)

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 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.
Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m2.
Subject has a Screening serum urate level ≥ 8 mg/dL.
Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Key exclusion criteria (8 listed)

Subject is unable to take colchicine for gout flare prophylaxis.
Subject has a history or suspicion of kidney stones.
Subject has any gastrointestinal disorder that affects motility and/or absorption.
Subject had 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.
Subject has 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 2.5 mgCohort 1: RDEA3170 2.5 mg, 7.5 mg (2.5 mg × 3 tablets), and 15 mg (2.5 mg × 6 tablets). Cohort 2: RDEA3170 5 mg (2.5 mg × 2 tablets), 10 mg (2.5 mg × 4 tablets), and 20 mg (2.5 mg × 8 tablets).	Drug	RDEA3170 2.5 mg, 7.5 mg and 15 mg, RDEA3170 5 mg, 10 mg and 20 mg
allopurinol 300 mgallopurinol 300 mg, allopurinol 600 mg (300 mg x 2 tablets)	Drug	RDEA3170 2.5 mg, 7.5 mg and 15 mg, RDEA3170 5 mg, 10 mg and 20 mg

Primary outcome

Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))
Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.
Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))
Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))
Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)
Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))
Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.
Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))
Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)
Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))
Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)

6 secondary outcomes

Maximum Observed Concentration (Cmax)
Time frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Time of Occurrence of Maximum Observed Concentration (Tmax)
Time frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
Time frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
Time frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Apparent Terminal Half-life (t1/2)
Time frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Number of Participants With Treatment-Emergent Adverse Events
Time frame: 11 weeks

Results and safety

Results posted to the registry on 23 Jan 2018, 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	20	20
Cohort 2	21	20

Primary outcome: Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))

Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose). Mean (Standard Error). Unit: Maximum Percentage (%) Change

Measure	Treatment A1 n = 20	Treatment A2q n = 10	Treatment A2b n = 10	Treatment R1 n = 20	Treatment R3 n = 20	Treatment R5 n = 20
Value	-40.2 (3.29)	-55.0 (4.96)	-56.8 (4.52)	-48.1 (2.91)	-61.0 (2.59)	-69.5 (2.09)

Primary outcome: Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.

Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose). Mean (Standard Error). Unit: mg/dL

Measure	Treatment A1 n = 20	Treatment A2q n = 10	Treatment A2b n = 10	Treatment R1 n = 20	Treatment R3 n = 20	Treatment R5 n = 20
Value	5.8 (0.24)	4.8 (0.38)	4.0 (0.39)	5.5 (0.24)	4.6 (0.22)	3.8 (0.18)

Primary outcome: Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))

Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose). Mean (Standard Error). Unit: Percentage (%) Change

Measure	Treatment A1 n = 20	Treatment A2q n = 10	Treatment A2b n = 10	Treatment R1 n = 20	Treatment R3 n = 20	Treatment R5 n = 20
Value	1065 (138)	1827 (252)	2633 (255)	899 (116)	958 (128)	827 (106)

Primary outcome: Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))

Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose). Mean (Standard Error). Unit: Percentage (%) Change

Measure	Treatment A1 n = 20	Treatment A2q n = 10	Treatment A2b n = 10	Treatment R1 n = 20	Treatment R3 n = 20	Treatment R5 n = 20
Value	400 (74.6)	517 (106)	827 (136)	310 (55.5)	311 (51.8)	305 (54.7)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 11 Weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	1 of 20 (5%)	6 of 20 (30%)	0 of 20
Cohort 2	0 of 21 (0%)	6 of 21 (28.6%)	0 of 21

Limitations and caveats (from the sponsor): Reliable urine uric acid values were not obtained due to sample processing errors, and this has resulted in the inability to assess the PD effects of RDEA3170 and/or allopurinol in urine.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29531784Fleischmann R, Winkle P, Miner JN, Yan X, Hicks L, Valdez S, Hall J, Liu S, Shen Z, Gillen M, Hernandez-Illas M. Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with allopurinol in adults with gout: a phase IIa, open-label study. RMD Open. 2018 Feb 8;4(1):e000584. doi: 10.1136/rmdopen-2017-000584. 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.

Jesse Hall, MD study director

Ardea Biosciences, Inc.

4 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 2.5 mg and allopurinol 300 mg in people with Gout, run by Ardea Biosciences, Inc. at 4 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 23 Jan 2018). 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?

Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) (time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)). The study lists 8 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 NCT02498652, which also lists 1 linked publication.

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 23 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.