GoutPhase 2NCT01407874
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
A Phase 2 study testing Ulodesine (BCX4208) 5 mg and Ulodesine (BCX4208) 10 mg in people with Gout and Hyperuricemia, run by BioCryst Pharmaceuticals at 10 sites in United States.
Trial summary
To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Gout, Hyperuricemia, Arthritis
- What is being tested?
- Ulodesine (BCX4208) 5 mg and Ulodesine (BCX4208) 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2011to Jul 2012
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 to < 70 years
- Have read and signed the Informed Consent Form
- Documented diagnosis of gout
- Documented moderate renal insufficiency
- Calculated creatinine clearance of ≥ 30 and < 60 mL/min
- Willing and able to take allopurinol 200 mg every day for the duration of the Treatment
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- Female participants must be sexually abstinent for 4 weeks prior to Day 1 and continue abstinence for 4 weeks after completion of study drug, surgically sterile, postmenopausal,use oral contraceptives for three months prior to study drug dosing through 4 weeks after completion of study drug, an intrauterine device for 8 weeks prior to study drug dosing through 4 weeks after completion of study drug,double barrier contraception method for 4 weeks prior to study drug dosing through 4 weeks after completion of study drug administration
- Male participants must be sexually abstinent for 4 weeks prior to Day 1 and continue abstinence through 90 days after completion of study drug, be > 1 year postvasectomy, agree to use a condom with spermicide from the start of study drug dosing through 90 days after completion of study drug.
- Willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability Act (HIPAA)
Who cannot join
- Unable to tolerate allopurinol 200 mg every day
- Prior randomization in a clinical study with BCX4208
- Unstable cardiac disease such as: unstable angina, symptomatic arrhythmia, signs or symptoms compatible with NYHA Class III or Class IV functional status for congestive heart failure or angina, history of long QT syndrome, or QTc interval < 350 msec or > 475 msec
- Poorly controlled hypertension
- History of severe renal insufficiency
- Alanine aminotransferase or aspartate aminotransferase values > 2.0 x upper limit of normal
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- CD4+ cell counts by flow cytometry < 500 cells/mm3
- Hemoglobin < 10 g/dL or > 18 g/dL (males) or < 10 g/dL or > 17 g/dL (females)
- White blood cell count < 3.7 x 109/L or > 11 x 109/L
- Female subjects who are pregnant, breastfeeding, or planning a pregnancy within the next 4 months
- Positive serology for hepatitis B surface antigen or hepatitis C antibody or HIV type 1
- Immunocompromised due to illness or organ transplant
- Use of systemic immunosuppressive medications or disease-modifying antirheumatic drugs
- Use of azathioprine or 6-mercatopurine within 14 days of first dose of allopurinol
- Use of hydrochlorothiazide in doses > 50 mg per day
- Planned use of herbal or dietary supplements
- Recipient of any live or attenuated vaccine within 6 weeks of Screening
- Planned use of uric acid-lowering drugs other than allopurinol
- Use of systemic corticosteroids within 4 weeks prior to Day 1
- Use of any investigational drug within 30 days prior to signing the ICF
- History of clinically significant and relevant drug allergies
- History of chronic or recurrent infections
- History of any type of cancer not successfully treated or in full remission for 12 months prior to Screening
- History of alcohol or drug abuse within the year prior to the signing of the ICF, or current evidence of substance dependence or abuse
- Use of other prohibited medications within the timeframes specified in the protocol
- Other medical conditions which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Alexandria, Virginia, 22304
Study site
Dallas, Texas, 75235
Study site
Honolulu, Hawaii, 96814
Study site
Irvine, California, 92618
Study site
Knoxville, Tennessee, 37923
Study site
Mobile, Alabama, 36608
Study site
Newton, Kansas, 67114
Study site
Oldsmar, Florida, 34677
Study site
Peoria, Arizona, 85381
Study site
San Antonio, Texas, 78215
About this study
To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency.
- Conditions
- Gout, Hyperuricemia, Arthritis, Joint Disease, Renal Insufficiency
- Being tested
- Placebo, Ulodesine (BCX4208) 5 mg, Ulodesine (BCX4208) 10 mg
- Keywords
- Gout, Hyperuricemia, Arthritis, Joint Disease, Allopurinol, Renal Insufficiency
- Medical subject headings
- Gout, Hyperuricemia, Arthritis, Joint Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral dose administered daily for 84 days.
Ulodesine (BCX4208) 5 mgDrug
Oral dose administered daily for 84 days.
Ulodesine (BCX4208) 10 mgDrug
Oral dose administered daily for 84 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Placebo + Allopurinol 200mg Receives: Drug: Placebo |
| Ulodesine (BCX4208) 5mg | Experimental | BCX4208 5mg + Allopurinol 200 mg Receives: Drug: Ulodesine (BCX4208) 5 mg |
| Ulodesine (BCX4208) 10mg | Experimental | BCX4208 10mg + Allopurinol 200mg Receives: Drug: Ulodesine (BCX4208) 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency by assessment of percent change from baseline in CD4+ lymphocytes at Day 85.
Level of CD4+ lymphocytes to be measured at Day 85 compared to baseline.
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Hollister, MD, PhD, Study director, BioCryst Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407874
- Sponsor's protocol ID
- BCX4208-204
- Status last verified
- Oct 2013
- First submitted
- 1 Aug 2011
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
- ClinicalTrials.gov ID
- NCT01407874
- Acronym / sponsor ID
- BCX4208-204
- Conditions
- Gout, Hyperuricemia, Arthritis, Joint Disease, Renal Insufficiency
- Keywords
- Gout, Hyperuricemia, Arthritis, Joint Disease, Allopurinol, Renal Insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Aug 2011 (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 evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: PlaceboPlacebo + Allopurinol 200mg |
| Ulodesine (BCX4208) 5mg | Experimental | Drug: Ulodesine (BCX4208) 5 mgBCX4208 5mg + Allopurinol 200 mg |
| Ulodesine (BCX4208) 10mg | Experimental | Drug: Ulodesine (BCX4208) 10 mgBCX4208 10mg + Allopurinol 200mg |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 to < 70 years
- Have read and signed the Informed Consent Form
- Documented diagnosis of gout
- Documented moderate renal insufficiency
- Calculated creatinine clearance of ≥ 30 and < 60 mL/min
Key exclusion criteria (26 listed)
- Unable to tolerate allopurinol 200 mg every day
- Prior randomization in a clinical study with BCX4208
- Unstable cardiac disease such as: unstable angina, symptomatic arrhythmia, signs or symptoms compatible with NYHA Class III or Class IV functional status for congestive heart failure or angina, history of long QT syndrome, or QTc interval < 350 msec or > 475 msec
- Poorly controlled hypertension
- History of severe renal insufficiency
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 |
|---|---|---|
| PlaceboOral dose administered daily for 84 days. | Drug | Placebo |
| Ulodesine (BCX4208) 5 mgOral dose administered daily for 84 days. | Drug | Ulodesine (BCX4208) 5mg |
| Ulodesine (BCX4208) 10 mgOral dose administered daily for 84 days. | Drug | Ulodesine (BCX4208) 10mg |
Primary outcome
To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency by assessment of percent change from baseline in CD4+ lymphocytes at Day 85.
Time frame: 85 days
Level of CD4+ lymphocytes to be measured at Day 85 compared to baseline.
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 20 Nov 2013.
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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.
Alan Hollister, MD, PhD study director
BioCryst Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ulodesine (BCX4208) 5 mg and Ulodesine (BCX4208) 10 mg in people with Gout and Hyperuricemia, run by BioCryst Pharmaceuticals at 10 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 9 inclusion and 26 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 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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 evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency by assessment of percent change from baseline in CD4+ lymphocytes at Day 85. (time frame: 85 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 20 Nov 2013.