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GoutPhase 2NCT01927198

RDEA3170 Monotherapy in Subjects With Gout

A Phase 2 study testing RDEA3170 5 mg, RDEA3170 10 mg and RDEA3170 12.5 mg in people with Gout, run by Ardea Biosciences, Inc. at 49 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 study will assess the serum uric acid lowering effects and safety of 3 dose levels of RDEA3170 compared to placebo in subjects with gout. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gout
What is being tested?
RDEA3170 5 mg, RDEA3170 10 mg and RDEA3170 12.5 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
172 participants
Where
49 sitesUnited States
Study dates
Aug 2013to Jul 2014
Phase
Phase 2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • Study site

    Altoona, Pennsylvania, 16602

  • Study site

    Anaheim, California, 92805

  • Study site

    Birmingham, Alabama, 35235

  • Study site

    Bountiful, Utah, 84010

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Cincinnati, Ohio, 45224

  • Study site

    Colorado Springs, Colorado, 80918

  • Study site

    Denver, Colorado, 80220

  • Study site

    Dunwoody, Georgia, 30338

  • Study site

    Elizabethtown, Kentucky, 42701

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Glendale, Arizona, 85308

  • Study site

    Gold River, California, 95670

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Gulf Shores, Alabama, 36542

  • Study site

    Gurnee, Illinois, 60031

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Honolulu, Hawaii, 96814

  • Study site

    Houston, Texas, 77098

  • Study site

    Irvine, California, 92618

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Jacksonville, Florida, 32205

  • Study site

    Lexington, Kentucky, 40503

  • Study site

    Meridian, Idaho, 83646

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Midlothian, Virginia, 23114

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    New York, New York, 10016

  • Study site

    Pembroke Pines, Florida, 33027

  • Study site

    Peoria, Arizona, 85381

  • Study site

    Perrysburg, Ohio, 43551

  • Study site

    Reno, Nevada, 89502

  • Study site

    Richmond, Virginia, 23219

  • Study site

    Rock Hill, South Carolina, 29732

  • Study site

    San Leandro, California, 94578

  • Study site

    San Ramon, California, 94582

  • Study site

    Shelby, North Carolina, 28150

  • Study site

    Shelby, North Carolina, 28152

  • Study site

    Spartanburg, South Carolina, 29303

  • Study site

    Spring Hill, Tennessee, 37174

  • Study site

    Tampa, Florida, 33606

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Virginia Beach, Virginia, 23462

  • Study site

    Willoughby Hills, Ohio, 44904

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Gout
Being tested
Placebo, RDEA3170 5 mg, RDEA3170 10 mg, RDEA3170 12.5 mg
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

  • RDEA3170 5 mgDrug

  • RDEA3170 10 mgDrug

  • RDEA3170 12.5 mgDrug

Study groups in NCT01927198
Study groupRoleWhat they receive
RDEA3170 5 mg qdExperimentalNo titration.
Receives: Drug: RDEA3170 5 mg
RDEA3170 10 mg qdExperimentalIncrease from RDEA3170 5 mg to RDEA3170 10 mg qd at Week 2.
Receives: Drug: RDEA3170 10 mg
RDEA3170 12.5 mg qdExperimentalIncrease from RDEA3170 10 mg to RDEA3170 12.5 mg qd at Week 4.
Receives: Drug: RDEA3170 12.5 mg
PlaceboPlacebo comparatorPlacebo group
Receives: Drug: Placebo

What is being measured

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

  1. Efficacy of RDEA3170 monotherapy at Week 12

    Percent change from baseline in serum urate levels at Week 12.

    Measured: Week 12

Secondary outcomes (2)

  1. Incidence of treatment-emergent adverse events and change from baseline in laboratory values, vital signs, and electrocardiograms

    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.

    Measured: 8 months

  2. Efficacy of RDEA3170 monotherapy at 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.

    Measured: Week 24

Timeline

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

  1. First posted22 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionMay 2014
  4. Study completionJul 2014

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01927198
Sponsor's protocol ID
RDEA3170-201
Status last verified
Jun 2015
First submitted
20 Aug 2013
Last updated
1 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RDEA3170 5 mg, RDEA3170 10 mg and RDEA3170 12.5 mg in people with Gout, run by Ardea Biosciences, Inc. at 49 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 3 inclusion and 20 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 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Efficacy of RDEA3170 monotherapy at Week 12 (time frame: Week 12). 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 NCT01927198.

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 1 Jul 2015.

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