HyperuricemiaPhase 2NCT00741442
A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
A Phase 2 study testing RDEA806 in people with Hyperuricemia, run by Ardea Biosciences, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- RDEA806
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Sep 2009
- 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
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Multicenter,Placebo-Controlled, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients.
- Conditions
- Hyperuricemia
- Being tested
- RDEA806, Placebo
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDEA806Drug
Uricosuric agent for the treatment of gout
PlaceboDrug
Matching Placebo.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | RDEA806 400 mg qd Receives: Drug: RDEA806 |
| 3 | Experimental | RDEA806 400 mg bid Receives: Drug: RDEA806 |
| 2 | Placebo comparator | Placebo QD Receives: Drug: Placebo |
| 4 | Placebo comparator | Placebo BID 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 uric acid (sUA) level is <6.0 mg/dL following 4 weeks of continuous treatment with RDEA806.
Measured: 4 weeks
Secondary outcomes (3)
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.
Measured: 4 weeks
To evaluate the absolute and percent reduction from baseline in sUA levels
Measured: 4 weeks
To evaluate percent change in 24-hour urine uric acid level
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2009
- Study completionSep 2009
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
- 3 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
- NCT00741442
- Sponsor's protocol ID
- RDEA806-501
- Status last verified
- Jan 2014
- First submitted
- 25 Aug 2008
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Multicenter,Placebo-Controlled, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
- ClinicalTrials.gov ID
- NCT00741442
- Acronym / sponsor ID
- RDEA806-501
- Conditions
- Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Aug 2008 (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.
The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients.
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 |
|---|---|---|
| 1 | Experimental | Drug: RDEA806RDEA806 400 mg qd |
| 3 | Experimental | Drug: RDEA806RDEA806 400 mg bid |
| 2 | Placebo comparator | Drug: PlaceboPlacebo QD |
| 4 | Placebo comparator | Drug: PlaceboPlacebo BID |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (20 listed)
- 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.
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 |
|---|---|---|
| RDEA806Uricosuric agent for the treatment of gout | Drug | 1, 3 |
| PlaceboMatching Placebo. | Drug | 2, 4 |
Primary outcome
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
3 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 visit.
Time frame: 4 weeks
To evaluate the absolute and percent reduction from baseline in sUA levels
Time frame: 4 weeks
To evaluate percent change in 24-hour urine uric acid level
Time frame: 4 weeks
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 6 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RDEA806 in people with Hyperuricemia, run by Ardea Biosciences, Inc. at 1 site in Canada.
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 4 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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 uric acid (sUA) level is <6.0 mg/dL following 4 weeks of continuous treatment with RDEA806. (time frame: 4 weeks). 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 6 Feb 2014.