Back to results

A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

Primary Purpose

Hyperuricemia

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

RDEA806

Placebo

About this trial

This is an interventional treatment trial for Hyperuricemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

RDEA806 400 mg qd

RDEA806 400 mg bid

Placebo QD

Placebo BID

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

To evaluate the absolute and percent reduction from baseline in sUA levels

To evaluate percent change in 24-hour urine uric acid level

Full Information

NCT ID

NCT00741442

First Posted

August 25, 2008

Last Updated

January 7, 2014

Sponsor

Ardea Biosciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00741442

Brief Title

A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

Official Title

Randomized, Double-Blind, Multicenter,Placebo-Controlled, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ardea Biosciences, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperuricemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

RDEA806 400 mg qd

Arm Title

Arm Type

Experimental

Arm Description

RDEA806 400 mg bid

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo QD

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo BID

Intervention Type

Drug

Intervention Name(s)

RDEA806

Intervention Description

Uricosuric agent for the treatment of gout

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching Placebo.

Primary Outcome Measure Information:

Title

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.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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.

Time Frame

4 weeks

Title

To evaluate the absolute and percent reduction from baseline in sUA levels

Time Frame

4 weeks

Title

To evaluate percent change in 24-hour urine uric acid level

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vijay Hingorani, MD, PhD, MBA

Organizational Affiliation

Ardea Biosciences, Inc.

Official's Role

Study Director

Facility Information:

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

We'll reach out to this number within 24 hrs