RDEA3170 Monotherapy in Subjects With Gout

June 4, 2015 updated by: Ardea Biosciences, Inc.

A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RDEA3170 Monotherapy in Subjects With Gout

This study will assess the serum uric acid lowering effects and safety of 3 dose levels of RDEA3170 compared to placebo in subjects with gout.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This monotherapy study is the initial Phase 2 study for RDEA3170 and is designed to compare the safety and efficacy of multiple dose levels of RDEA3170 with placebo when given for up to 24 weeks to subjects with gout. The placebo control for RDEA3170 is included in this study to minimize bias in study assessments and monitoring. Further, to accomplish the goal of understanding the safety profile of RDEA3170, it is important to compare RDEA3170 monotherapy with placebo for at least 24 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
      • Gulf Shores, Alabama, United States, 36542
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Glendale, Arizona, United States, 85308
      • Peoria, Arizona, United States, 85381
      • Tucson, Arizona, United States, 85704
    • California
      • Anaheim, California, United States, 92805
      • Gold River, California, United States, 95670
      • Irvine, California, United States, 92618
      • San Leandro, California, United States, 94578
      • San Ramon, California, United States, 94582
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
      • Denver, Colorado, United States, 80220
    • Florida
      • Jacksonville, Florida, United States, 32205
      • Pembroke Pines, Florida, United States, 33027
      • Tampa, Florida, United States, 33606
      • Winter Haven, Florida, United States, 33880
    • Georgia
      • Dunwoody, Georgia, United States, 30338
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
    • Idaho
      • Meridian, Idaho, United States, 83646
    • Illinois
      • Gurnee, Illinois, United States, 60031
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
      • Lexington, Kentucky, United States, 40503
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Mississippi
      • Jackson, Mississippi, United States, 39202
    • Nevada
      • Reno, Nevada, United States, 89502
    • New York
      • New York, New York, United States, 10016
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
      • Hickory, North Carolina, United States, 28602
      • Shelby, North Carolina, United States, 28150
      • Shelby, North Carolina, United States, 28152
      • Wilmington, North Carolina, United States, 28401
      • Winston-Salem, North Carolina, United States, 27103
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Cincinnati, Ohio, United States, 45224
      • Perrysburg, Ohio, United States, 43551
      • Perrysburgh, Ohio, United States, 43551
      • Willoughby Hills, Ohio, United States, 44904
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
    • South Carolina
      • Greenville, South Carolina, United States, 29615
      • Greer, South Carolina, United States, 29651
      • Mount Pleasant, South Carolina, United States, 29464
      • Rock Hill, South Carolina, United States, 29732
      • Spartanburg, South Carolina, United States, 29303
    • Tennessee
      • Spring Hill, Tennessee, United States, 37174
    • Texas
      • Houston, Texas, United States, 77098
    • Utah
      • Bountiful, Utah, United States, 84010
    • Virginia
      • Midlothian, Virginia, United States, 23114
      • Richmond, Virginia, United States, 23219
      • Virginia Beach, Virginia, United States, 23462

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject meets the diagnosis of gout per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
  • Subject has a serum urate level ≥ 6.5 mg/dL and ≤ 10.0 mg/dL during the Screening Period.
  • Subject has a body mass index < 40 kg/m2.

Exclusion Criteria:

  • Subject is pregnant or breastfeeding. Subject consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
  • Subject has a history or suspicion of kidney stones.
  • Subject has a history or suspicion of drug abuse within the past 5 years.
  • Subject has a history of symptomatic myositis/myopathy or rhabdomyolysis.
  • Subject has a known or suspected human immunodeficiency virus infection.
  • Subject has a positive test for active hepatitis B or hepatitis C infection.
  • Subject has a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ Grade 1 cervical cancer.
  • Subject within the last 12 months with: unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis; or subjects currently receiving anticoagulants.
  • Subject has a QT interval corrected for heart rate according to Fridericia's formula > 450 msec during the Screening Period, confirmed by a repeat assessment.
  • Subject has uncontrolled hypertension.
  • Subject has an estimated creatinine clearance < 60 mL/min.
  • Subject has an alkaline phosphatase > 2.0 x upper limit of normal during the Screening Period.
  • Subject has active liver disease or impaired hepatic function.
  • Subject is receiving chronic treatment with more than 325 mg salicylates per day.
  • Subject has a medical condition that requires or may require systemic immunosuppressive (eg, chronic low-dose oral prednisone) or immunomodulatory treatment.
  • Subject is unable to take colchicine for gout flare prophylaxis.
  • Subject is receiving strong or moderate CYP3A inhibitors, p-glycoprotein inhibitors, or digoxin.
  • Subject received any strong enzyme- inducing drug or product (eg, rifampin, rifabutin, phenytoin, phenobarbital, St. John's Wort) within 2 months prior to Day 1 or refuses to refrain from taking these medications until the end of the study.
  • Subject received an investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to the Screening Period.
  • Subject has any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo group
Drug: Placebo
Experimental: RDEA3170 5 mg qd
No titration.
Drug: RDEA3170 5 mg
Experimental: RDEA3170 10 mg qd
Increase from RDEA3170 5 mg to RDEA3170 10 mg qd at Week 2.
Drug: RDEA3170 10 mg
Experimental: RDEA3170 12.5 mg qd
Increase from RDEA3170 10 mg to RDEA3170 12.5 mg qd at Week 4.
Drug: RDEA3170 12.5 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of RDEA3170 monotherapy at Week 12
Time Frame: Week 12
Percent change from baseline in serum urate levels at Week 12.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events and change from baseline in laboratory values, vital signs, and electrocardiograms
Time Frame: 8 months
Safety assessments include adverse event (AE) recording, gout flare recording, clinical safety laboratory tests (eg, hematology, serum chemistry, and urinalysis), physical examinations, vital sign measurements, and ECGs.
8 months
Efficacy of RDEA3170 monotherapy at Week 24
Time Frame: Week 24
Percent change from baseline in serum urate levels at each visit. Proportion of subjects with a serum urate level < 6.0 and < 5.0 mg/dL at each visit.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ardea Biosciences, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: J. Hall, MD, Ardea Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RDEA3170-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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