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GoutPhase 2NCT01265264

Study to Evaluate sUA Lowering Activity, Safety and Efficacy of Oral Ulodesine Added to Allopurinol

A Phase 2 study testing ulodesine in people with Gout and Hyperuricemia, run by BioCryst Pharmaceuticals at 54 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

The purpose of this study is to determine whether ulodesine and allopurinol combined for 12 weeks are effective in treating gout in patients who are not adequately responding to allopurinol alone. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
279 participants
Where
54 sitesUnited States
Study dates
Dec 2010to Feb 2013
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
  • Baseline sUA ≥ 6.0 mg/dL after at least 2 weeks of treatment on a stable 300 mg dose of allopurinol
  • Documented diagnosis of gout according to the American Rheumatism Association --Preliminary Criteria for the Diagnosis of Gout
  • Be willing and able to take colchicine 0.6 mg per day or naproxen 220-250 mg twice daily as prophylaxis for gout flares and, if needed, a single daily dose of a proton pump inhibitor to prevent gastrointestinal discomfort
  • Female participants must:
  • Be sexually abstinent
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  • Be surgically sterile
  • Be postmenopausal or on stable contraception
  • Male participants must:
  • Be sexually abstinent
  • Be > 1 year post-vasectomy
  • Using condoms with spermicide with partners meeting female requirements

Who cannot join

  • Unable to tolerate 300 mg allopurinol
  • Unable to tolerate both colchicine 0.6 mg per day and naproxen 220-250 mg twice daily
  • Prior participation in a clinical study with BCX4208
  • Gout flare during the Screening Period that is resolved for less than 2 weeks prior to first treatment with BCX4208 or placebo (exclusive of chronic synovitis/ arthritis)
  • Unstable angina, symptomatic arrhythmia, signs or symptoms compatible with New York Heart Association Class III or Class IV heart failure, history of long QT syndrome, or QTc interval < 350 msec or > 475 msec
  • Poorly controlled hypertension (SBP > 160 mmHg or DBP > 100 mmHG at Screening or Baseline)
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  • Moderate or severe renal impairment and/or calculated creatinine clearance of < 60 mL/min(Cockroft-Gault method)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values > 2.0 x ULN
  • 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 or HIV type 1
  • Immunocompromised or on systemic immunosuppressive medications or antirheumatic drugs (including anakinra and adrenocorticotropic hormone)from Screening to Day 92
  • Azathioprine or 6-mercaptopurine within 14 days of first dose of allopurinol Hydrochlorothiazide in doses > 50 mg per day from Screening to Day 92
  • Use of herbal/dietary supplements Screening to Day 92
  • Recipient of any live or attenuated vaccine within 6 weeks of Screening
  • Uric acid-lowering drugs other than allopurinol from Screening to Day 92 Systemic corticosteroids within 4 weeks prior to Day 1 (this does not include pulmonary or nasal inhaler containing corticosteroids, ophthalmic corticosteroids, joint injections, or low potency topical steroids)
  • Investigational drug within 30 days prior to signing the ICF for this study
  • Clinically significant and relevant drug allergies
  • Chronic or recurrent infections (≥ 3 infections at the same site within 12 months)
  • Cancer within 12 months-Except non-melanomatous localized skin cancer or completely excised and cured carcinoma-in-situ of uterine cervix or subjects who were previously treated for prostate or breast cancer if they currently are stable and have not been on chemo therapy within the last year prior to screening.
  • Alcohol or drug abuse within 12 months of signing the ICF, or current substance dependence or abuse
  • Other medical conditions which, in the opinion of the PI, would jeopardize the safety of the study subject or impact the validity of the study results.

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Anaheim, California

  • Study site

    Atlanta, Georgia

  • Study site

    Baltimore, Maryland

  • Study site

    Birmingham, Alabama

  • Study site

    Bristol, Tennessee

  • Study site

    Brownsburg, Indiana

  • Study site

    Burbank, California

  • Study site

    Charlotte, North Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Dallas, Texas

  • Study site

    DeLand, Florida

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Edgewater, Florida

  • Study site

    Gainesville, Florida

  • Study site

    Greensboro, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Gurnee, Illinois

  • Study site

    Honolulu, Hawaii

  • Study site

    Irvine, California

  • Study site

    La Mesa, California

  • Study site

    Lansing, Michigan

  • Study site

    Lexington, Kentucky

  • Study site

    Los Angeles, California

  • Study site

    Malvern, Arkansas

  • Study site

    Meridian, Idaho

  • Study site

    Miami, Florida

  • Study site

    Mobile, Alabama

  • Study site

    Newton, Kansas

  • Study site

    Oceanside, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Oldsmar, Florida

  • Study site

    Olive Branch, Mississippi

  • Study site

    Omaha, Nebraska

  • Study site

    Palm Springs, California

  • Study site

    Paramount, California

  • Study site

    Phoenix, Arizona

  • Study site

    Raleigh, North Carolina

  • Study site

    Rapid City, South Dakota

  • Study site

    Richmond, Virginia

  • Study site

    Sacramento, California

  • Study site

    Salisbury, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Jose, California

  • Study site

    Sanford, Florida

  • Study site

    Scottsdale, Arizona

  • Study site

    Springfield, Massachusetts

  • Study site

    Tacoma, Washington

  • Study site

    Tucson, Arizona

  • Study site

    Walnut Creek, California

  • Study site

    West Covina, California

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Dose-Response Study of the Safety and Efficacy of Oral Ulodesine Added to Allopurinol in Subjects With Gout Who Have Not Adequately Responded to Allopurinol Monotherapy

The purpose of this study is to determine whether ulodesine and allopurinol combined for 12 weeks are effective in treating gout in patients who are not adequately responding to allopurinol alone.

Being tested
ulodesine, Placebo
Keywords
Gout, hyperuricemia, arthritis, joint diseases, allopurinol
Medical subject headings
Gout, Hyperuricemia, Arthritis, Joint Diseases

What participants receive

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

  • ulodesineDrug

    Oral dose administered daily for 84 days.

  • PlaceboDrug

    Oral dose administered daily for 84 days.

Study groups in NCT01265264
Study groupRoleWhat they receive
ulodesine Placebo + Allopurinol 300mgExperimentalOral dose administered daily for 84 days.
Receives: Drug: ulodesine; Drug: Placebo
ulodesine 5mg + Allopurinol 300mgExperimentalOral dose administered daily for 84 days.
Receives: Drug: ulodesine; Drug: Placebo
ulodesine 10mg + Allopurinol 300mgExperimentalOral dose administered daily for 84 days.
Receives: Drug: ulodesine; Drug: Placebo
ulodesine 20mg + Allopurinol 300mgExperimentalOral dose administered daily for 84 days.
Receives: Drug: ulodesine; Drug: Placebo
ulodesine 40mg + Allopurinol 300mgExperimentalOral dose administered daily for 84 days.
Receives: Drug: ulodesine; Drug: Placebo

What is being measured

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

  1. To evaluate the dose response of ulodesine when combined with Allopurinol on sUA.

    Level of serum uric acid levels be measured at Day 85 to evaluate in subjects with Gout.

    Measured: Day 85

Timeline

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

  1. First posted23 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJul 2012
  4. Study completionFeb 2013

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01265264
Sponsor's protocol ID
BCX4208-203
Status last verified
Oct 2013
First submitted
20 Dec 2010
Last updated
20 Nov 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ulodesine in people with Gout and Hyperuricemia, run by BioCryst Pharmaceuticals at 54 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 12 inclusion and 23 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 54 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 dose response of ulodesine when combined with Allopurinol on sUA. (time frame: Day 85). 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 NCT01265264.

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.

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