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

October 28, 2013 updated by: BioCryst Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Malvern, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Burbank, California, United States
      • Irvine, California, United States
      • La Mesa, California, United States
      • Los Angeles, California, United States
      • Oceanside, California, United States
      • Palm Springs, California, United States
      • Paramount, California, United States
      • Sacramento, California, United States
      • San Jose, California, United States
      • Walnut Creek, California, United States
      • West Covina, California, United States
    • Florida
      • Deland, Florida, United States
      • Edgewater, Florida, United States
      • Gainesville, Florida, United States
      • Miami, Florida, United States
      • Oldsmar, Florida, United States
      • Sanford, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Idaho
      • Meridian, Idaho, United States
    • Illinois
      • Gurnee, Illinois, United States
    • Indiana
      • Brownsburg, Indiana, United States
    • Kansas
      • Newton, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • Michigan
      • Lansing, Michigan, United States
    • Mississippi
      • Olive Branch, Mississippi, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
    • South Carolina
      • Greer, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Bristol, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Richmond, Virginia, United States
    • Washington
      • Tacoma, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ulodesine Placebo + Allopurinol 300mg
Oral dose administered daily for 84 days.
Drug: Placebo
Oral dose administered daily for 84 days.
Drug: ulodesine
Oral dose administered daily for 84 days.
EXPERIMENTAL: ulodesine 5mg + Allopurinol 300mg
Oral dose administered daily for 84 days.
Drug: Placebo
Oral dose administered daily for 84 days.
Drug: ulodesine
Oral dose administered daily for 84 days.
EXPERIMENTAL: ulodesine 10mg + Allopurinol 300mg
Oral dose administered daily for 84 days.
Drug: Placebo
Oral dose administered daily for 84 days.
Drug: ulodesine
Oral dose administered daily for 84 days.
EXPERIMENTAL: ulodesine 20mg + Allopurinol 300mg
Oral dose administered daily for 84 days.
Drug: Placebo
Oral dose administered daily for 84 days.
Drug: ulodesine
Oral dose administered daily for 84 days.
EXPERIMENTAL: ulodesine 40mg + Allopurinol 300mg
Oral dose administered daily for 84 days.
Drug: Placebo
Oral dose administered daily for 84 days.
Drug: ulodesine
Oral dose administered daily for 84 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioCryst Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 22, 2010

First Posted (ESTIMATE)

December 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCX4208-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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