Allopurinol Combination Study

ClinicalTrials.gov ID: NCT01001338

Public ClinicalTrials.gov record NCT01001338. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Nov 6, 2026, 5:17 AM EST

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Official title

Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Safety, Efficacy and Potential Pharmacokinetic Interaction of RDEA594 and Allopurinol in Gout Patients With an Inadequate Hypouricemic Response With Standard Doses of Allopurinol

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To compare the proportion of subjects whose serum urate (sUA) levels are \< 6.0 mg/dL following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response with standard doses of allopurinol.

Study identification

NCT ID: NCT01001338
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Ardea Biosciences, Inc.; Industry
Enrollment: 227 participants

Conditions and interventions

Conditions

Gout

Interventions

RDEA594 Drug
Placebo Drug
Allopurinol Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 80 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 2009 (Type not available)
Primary completion: Jan 2011 (Actual)
Completion: Aug 2016 (Actual)
Last update posted: Jan 24, 2017

2009 – 2016

United States locations

U.S. sites: 25
U.S. states: 14
U.S. cities: 25

Facility	City	State	ZIP	Site status
Not listed	Phoenix	Arizona	85050	—
Not listed	La Jolla	California	92037	—
Not listed	Los Angeles	California	90017	—
Not listed	Stanford	California	94305	—
Not listed	Boca Raton	Florida	33432	—
Not listed	DeLand	Florida	32720	—
Not listed	Fort Lauderdale	Florida	33334	—
Not listed	Jupiter	Florida	33458	—
Not listed	Meridan	Idaho	83642	—
Not listed	Lexington	Kentucky	40504	—
Not listed	Wheaton	Maryland	20902	—
Not listed	Las Vegas	Nevada	89183	—
Not listed	Reno	Nevada	89502	—
Not listed	Harrisburg	North Carolina	28075	—
Not listed	Cincinnati	Ohio	45242	—
Not listed	Cleveland	Ohio	44122	—
Not listed	Mayfield Village	Ohio	44143	—
Not listed	Durham	South Carolina	27710	—
Not listed	Rock Hill	South Carolina	29732	—
Not listed	Germantown	Tennessee	38138	—
Not listed	Jackson	Tennessee	38305	—
Not listed	Dallas	Texas	75231	—
Not listed	San Antonio	Texas	78221	—
Not listed	West Jordan	Utah	84088	—
Not listed	Chesapeake	Virginia	23320	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01001338, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 24, 2017 · Synced Nov 6, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01001338 live on ClinicalTrials.gov.

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