HyperuricemiaPhase 2NCT00955981
Gout Dose Response Study
A Phase 2 study testing RDEA594 in people with Hyperuricemia, run by Ardea Biosciences, Inc. at 29 sites in 7 countries.
Trial summary
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- RDEA594
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 29 sitesin 7 countries
- Study dates
- Jul 2009to Sep 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or post-menopausal or surgically sterile female.
- 18 - 75 years of age.
- Hyperuricemic (i.e., screening sUA ≥8 mg/dL).
- Meets criteria for the diagnosis of gout as per the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
- Willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed).
- Subjects entering the optional Extension Period must have successfully completed the Double-Blind Treatment Period and Follow-up Period within approximately 4 months and must not have experienced any serious adverse events considered possibly related to study drug.
Who cannot join
- Classified as an overproducer of urine urate (Cur > 6.0 ml/min/1.73 m2 24- hour urine).
- Consumes more than 14 drinks of alcohol per week (e.g., 1 drink = 5 oz [150 ml] of wine, 12 oz [360 ml] of beer, or 1.5 oz [45 ml] of hard liquor).
- History or suspicion of drug abuse.
- Documented history of or suspicion of kidney stones.
- History of rheumatoid arthritis or other autoimmune disease.
- Confirmed (positive serology to HIV1 and HIV 2) or suspected HIV infection.
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- Positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
- History of malignancy, except treated non-melanomatous skin cancer or cervical dysplasia.
- History of cardiac abnormalities, including abnormal and clinically relevant ECG changes such as bradycardia (sinus rate <45 bpm), complete left bundle branch block (LBBB), second or third degree heart block, intraventricular conduction delay with QRS duration >120 msec, symptomatic or asymptomatic arrhythmias with the exception of sinus arrhythmia, evidence of ventricular pre-excitation, frequent palpitations or syncopal episodes, heart failure, hypokalemia, family history of Long QT Syndrome, and/or family history of sudden death in an otherwise healthy individual between the ages of 1 and 30 years.
- Any condition predisposing them to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
- Any use of a concomitant medication that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 0)
- QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at Screening or pre-dose at Baseline (Day 0)
- Uncontrolled hypertension (above 150/95)
- Inadequate renal function
- Hemoglobin < 10 g/dL (males) or < 9 g/dL (females)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN)
- Gamma glutamyl transferase (GGT) > 3 x ULN
- Active peptic ulcer disease requiring treatment
- History of xanthinuria, active liver disease, or hepatic dysfunction.
- Requires therapy with any other urate-lowering medication, other than the study medication.
- Requires long-term use of salicylates; diuretics; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim
- Taking medications known as enzyme inducers
- Receiving a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within 1 month prior to study drug dosing
- Gout flare at screening that is resolved for less than one week prior to the first treatment with study medication (exclusive of chronic synovitis/ arthritis)
- Female of childbearing potential
- Received an investigational medication within 4 weeks prior to study medication administration
- Previously participated in a clinical study involving RDEA806 or RDEA594.
- Known hypersensitivity or allergy to RDEA594 or colchicine or any components in their formulations.
- Body mass index (BMI) >40 kg/m2.
- Taking greater than 1000 mg/day of Vitamin C.
- 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.
- Inadequate renal function after completing the Double-Blind Treatment period prior to entering Extension Period.
- Requiring treatment with prohibited medications noted in exclusion criteria numbers 20-23 after completing the Double-Blind Treatment Period prior to entering the Extension Period.
- Clinically relevant medical event as determined by the investigator in consultation with medical monitor prior to entering the Extension Period.
Trial locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
Bulgaria6 sites
Study site
Pleven, 5800
Study site
Plovdiv, 4002
Study site
Plovidv, 4002
Study site
Sofia, 1233
Study site
Sofia, 1709
Study site
Varna, 9010
Poland6 sites
Study site
Elblag, 82-300
Study site
Lodz, 90-153
Study site
Lublin, 20-607
Study site
Poznan, 61-289
Study site
Radom, 26-610
Study site
Wroclaw, 53-025
Canada5 sites
Study site
Coquitlam, British Columbia, V3K 3P4
Study site
Kelowna, British Columbia, V1Y8E7
Study site
Mirabel, Quebec, J7J 2K8
Study site
Thornhill, Ontario, L4J6W6
Study site
Toronto, Ontario, M9W 4L6
United States4 sites
Study site
DeLand, Florida, 32720
Study site
Jackson, Tennessee, 38305
Study site
Los Angeles, California, 90017
Study site
Winston-Salem, North Carolina, 27103
Czechia3 sites
Study site
Bruntál, 792 01
Study site
Prague, 140 00
Study site
Prague, 148 00
Germany3 sites
Study site
Goch, 47574
Study site
Hamburg, 22143
Study site
Nuremberg, 90402
About this study
Official title: Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients With Gout
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
- Conditions
- Hyperuricemia
- Being tested
- RDEA594, Placebo
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDEA594Drug
Uricosuric agent for the treatment of gout
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| RDEA594 200 mg qd for 28 days | Experimental | Not described Receives: Drug: RDEA594 |
| RDEA594 200 mg, 400 mg | Experimental | RDEA594 200 mg qd for 7 days followed by 400 mg qd for 21 days Receives: Drug: RDEA594 |
| RDEA594 200 mg, 400 mg and 600 mg | Experimental | RDEA594 200 mg qd for 7 days followed by 400 mg qd for 7 days followed by 600 mg qd for 14 days Receives: Drug: RDEA594 |
| Matching placebo | Placebo comparator | RDEA594 matching placebo qd for 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
Measured: 28 Days
Secondary outcomes (6)
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 weekly study visit during the Double-Blind Period.
Measured: 28 Days
To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit.
Measured: 28 Days and through extension
To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28.
Measured: 28 Days and through extension
To evaluate the incidence of gout flares.
Measured: 28 Days and through extension
To evaluate the safety and tolerability of RDEA594 in subjects with gout.
Measured: 28 Days and through extension
To evaluate the proportion of subjects whose sUA level decreases to or is maintained at <6.0 mg/dL in the Open-Label Extension Period.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardea Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vijay Hingorani, MD, PhD, MBA, Study director, Ardea Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955981
- Sponsor's protocol ID
- RDEA594-202
- Status last verified
- Feb 2014
- First submitted
- 7 Aug 2009
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients With Gout
- ClinicalTrials.gov ID
- NCT00955981
- Acronym / sponsor ID
- RDEA594-202
- Conditions
- Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RDEA594 200 mg qd for 28 days | Experimental | Drug: RDEA594 |
| RDEA594 200 mg, 400 mg | Experimental | Drug: RDEA594RDEA594 200 mg qd for 7 days followed by 400 mg qd for 21 days |
| RDEA594 200 mg, 400 mg and 600 mg | Experimental | Drug: RDEA594RDEA594 200 mg qd for 7 days followed by 400 mg qd for 7 days followed by 600 mg qd for 14 days |
| Matching placebo | Placebo comparator | Drug: PlaceboRDEA594 matching placebo qd for 28 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or post-menopausal or surgically sterile female.
- 18 - 75 years of age.
- Hyperuricemic (i.e., screening sUA ≥8 mg/dL).
- Meets criteria for the diagnosis of gout as per the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
- Willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed).
Key exclusion criteria (34 listed)
- Classified as an overproducer of urine urate (Cur > 6.0 ml/min/1.73 m2 24- hour urine).
- Consumes more than 14 drinks of alcohol per week (e.g., 1 drink = 5 oz [150 ml] of wine, 12 oz [360 ml] of beer, or 1.5 oz [45 ml] of hard liquor).
- History or suspicion of drug abuse.
- Documented history of or suspicion of kidney stones.
- History of rheumatoid arthritis or other autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDEA594Uricosuric agent for the treatment of gout | Drug | RDEA594 200 mg qd for 28 days, RDEA594 200 mg, 400 mg, RDEA594 200 mg, 400 mg and 600 mg |
| PlaceboMatching placebo | Drug | Matching placebo |
Primary outcome
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
Time frame: 28 Days
6 secondary outcomes
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 weekly study visit during the Double-Blind Period.
Time frame: 28 Days
To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit.
Time frame: 28 Days and through extension
To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28.
Time frame: 28 Days and through extension
To evaluate the incidence of gout flares.
Time frame: 28 Days and through extension
To evaluate the safety and tolerability of RDEA594 in subjects with gout.
Time frame: 28 Days and through extension
To evaluate the proportion of subjects whose sUA level decreases to or is maintained at <6.0 mg/dL in the Open-Label Extension Period.
Time frame: 18 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay Hingorani, MD, PhD, MBA study director
Ardea Biosciences, Inc.
29 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RDEA594 in people with Hyperuricemia, run by Ardea Biosciences, Inc. at 29 sites in 7 countries.
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 6 inclusion and 34 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 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Bulgaria, Poland, Canada, United States, Czechia and 2 more countries. 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?
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group. (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2014.