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

NCT01265264 | Completed Phase 2 DMC

• 1 other identifier: BCX4208-203
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 54

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.

Conditions

Gout; Hyperuricemia; Arthritis; Joint Disease

Keywords

Gout; hyperuricemia; arthritis; joint diseases; allopurinol

Outcome Measures

Primary Outcomes (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.

  Day 85

Study Arms (5)

ulodesine Placebo + Allopurinol 300mg

EXPERIMENTAL

Oral dose administered daily for 84 days.

Drug: ulodesine; Drug: Placebo

ulodesine 5mg + Allopurinol 300mg

EXPERIMENTAL

Oral dose administered daily for 84 days.

Drug: ulodesine; Drug: Placebo

ulodesine 10mg + Allopurinol 300mg

EXPERIMENTAL

Oral dose administered daily for 84 days.

Drug: ulodesine; Drug: Placebo

ulodesine 20mg + Allopurinol 300mg

EXPERIMENTAL

Oral dose administered daily for 84 days.

Drug: ulodesine; Drug: Placebo

ulodesine 40mg + Allopurinol 300mg

EXPERIMENTAL

Oral dose administered daily for 84 days.

Drug: ulodesine; Drug: Placebo

Interventions

ulodesine DRUG

Oral dose administered daily for 84 days.

ulodesine 10mg + Allopurinol 300mg; ulodesine 20mg + Allopurinol 300mg; ulodesine 40mg + Allopurinol 300mg; ulodesine 5mg + Allopurinol 300mg; ulodesine Placebo + Allopurinol 300mg

Placebo DRUG

Oral dose administered daily for 84 days.

ulodesine 10mg + Allopurinol 300mg; ulodesine 20mg + Allopurinol 300mg; ulodesine 40mg + Allopurinol 300mg; ulodesine 5mg + Allopurinol 300mg; ulodesine Placebo + Allopurinol 300mg

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead

Study Sites (54)

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Malvern, Arkansas, United States

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Anaheim, California, United States

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Burbank, California, United States

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Irvine, California, United States

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La Mesa, California, United States

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Los Angeles, California, United States

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Oceanside, California, United States

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Palm Springs, California, United States

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Paramount, California, United States

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Sacramento, California, United States

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San Jose, California, United States

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Walnut Creek, California, United States

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West Covina, California, United States

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DeLand, Florida, United States

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Edgewater, Florida, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Oldsmar, Florida, United States

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Sanford, Florida, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Meridian, Idaho, United States

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Gurnee, Illinois, United States

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Brownsburg, Indiana, United States

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Newton, Kansas, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Springfield, Massachusetts, United States

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Lansing, Michigan, United States

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Olive Branch, Mississippi, United States

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Omaha, Nebraska, United States

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Albuquerque, New Mexico, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Greer, South Carolina, United States

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Rapid City, South Dakota, United States

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Bristol, Tennessee, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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MeSH Terms

Conditions

Gout; Hyperuricemia; Arthritis; Joint Diseases

Interventions

ulodesine

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alan Hollister, MD, PhD

  BioCryst Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 23, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: February 1, 2013
• Last Updated: November 20, 2013

Record last verified: 2013-10

Locations

US (54)