A Study of RDEA806 in Hyperuricemic Subjects With Symptom... | NCT00741442

Studies
A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

NCT00741442

Sponsor

Ardea Biosciences, Inc.

Status

Completed

Last Update Posted

Feb 6, 2014Estimated

Enrollment

3Actual

Phase

Phase 2

Conditions

Hyperuricemia

Interventions

RDEA806
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Aug 25, 2008

First Submission Date that Met QC Criteria

Aug 25, 2008

First Posted Date

Aug 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jan 7, 2014

Certification/Extension First Submitted that Passed QC Review

Jan 7, 2014

Certification/Extension First Posted Date

Feb 6, 2014Estimated

Last Update Submitted Date

Jan 7, 2014

Last Update Posted Date

Feb 6, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	RDEA806 400 mg qd	Drug: RDEA806
3	Experimental	RDEA806 400 mg bid	Drug: RDEA806
2	Placebo Comparator	Placebo QD	Drug: Placebo
4	Placebo Comparator	Placebo BID	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RDEA806	Drug	Uricosuric agent for the treatment of gout	1 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the proportion of subjects whose serum uric acid (sUA) level is <6.0 mg/dL following 4 weeks of continuous treatment with RDEA806.		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the proportion of subjects whose sUA levels are <6.0 mg/dL, <5.0 mg/dL and <4.0 mg/dL, at each visit.		4 weeks
To evaluate the absolute and percent reduction from baseline in sUA levels		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is hyperuricemic: screening serum uric acid ≥8 mg/dL.
Patient meets one or more of the 1977 ARA criteria for the diagnosis of gout.
Patient is willing and able to give informed consent and adhere to visit/protocol schedules
All female subjects of child-bearing potential must agree to use a barrier method of birth control (e.g. condom, diaphragm or cap).

Exclusion Criteria:

Consumes more than 14 drinks of alcohol per week.
History or suspicion of drug abuse.
History of kidney stones, rheumatoid arthritis or other autoimmune disease, significant cardiac dysfunction.
Diabetes Mellitus requiring treatment
Confirmed or suspected HIV-1 infection.
Malignancy, except treated non-melanomatous skin cancer and cervical dysplasia.
Uncontrolled hypertension.
Inadequate renal function.
Hemoglobin < 8 g/dL (males) or < 7 g/dL (females).
ALT, AST , or GGT 2 x ULN
Active peptic ulcer disease.
Requires long-term use of salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; IV colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; trimethoprim.
Pregnant or breast feeding.
Use of an investigational drug within 4 weeks prior to study drug administration.
Known hypersensitivity or allergy to RDEA806 or colchicine or any components in their formulations.
Any other medical or psychological condition which, in the opinion of the investigator, 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.
History of cardiac abnormalities including abnormal and clinically relevant ECG changes.
Conditions predisposing to QT prolongation.
Any use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day 1.
Subjects with a QTcF interval >450 milliseconds at screening or on Day -1 or at pre-dose (Hour 0) on Day 1.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms