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

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ClinicalTrials.gov Identifier: NCT01265264
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : November 20, 2013
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Gout Hyperuricemia Arthritis Joint Disease Drug: ulodesine Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout

Arms and Interventions
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Arm Intervention/treatment
Experimental: ulodesine Placebo + Allopurinol 300mg
Oral dose administered daily for 84 days.
 Drug: ulodesine
Oral dose administered daily for 84 days.

Drug: Placebo
Oral dose administered daily for 84 days.
Experimental: ulodesine 5mg + Allopurinol 300mg
Oral dose administered daily for 84 days.
 Drug: ulodesine
Oral dose administered daily for 84 days.

Drug: Placebo
Oral dose administered daily for 84 days.
Experimental: ulodesine 10mg + Allopurinol 300mg
Oral dose administered daily for 84 days.
 Drug: ulodesine
Oral dose administered daily for 84 days.

Drug: Placebo
Oral dose administered daily for 84 days.
Experimental: ulodesine 20mg + Allopurinol 300mg
Oral dose administered daily for 84 days.
 Drug: ulodesine
Oral dose administered daily for 84 days.

Drug: Placebo
Oral dose administered daily for 84 days.
Experimental: ulodesine 40mg + Allopurinol 300mg
Oral dose administered daily for 84 days.
 Drug: ulodesine
Oral dose administered daily for 84 days.

Drug: Placebo
Oral dose administered daily for 84 days.


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the dose response of ulodesine when combined with Allopurinol on sUA. [ Time Frame: Day 85 ]
    Level of serum uric acid levels be measured at Day 85 to evaluate in subjects with Gout.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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)
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265264


  Show 54 Study Locations
Sponsors and Collaborators
BioCryst Pharmaceuticals
Investigators
Study Director: Alan Hollister, MD, PhD BioCryst Pharmaceuticals
More Information
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Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01265264     History of Changes
Other Study ID Numbers: BCX4208-203
First Posted: December 23, 2010    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: October 2013

Keywords provided by BioCryst Pharmaceuticals:
Gout
hyperuricemia
arthritis
joint diseases
allopurinol

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Hyperuricemia
Musculoskeletal Diseases
Pathologic Processes
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs