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Allopurinol Outcome Study (LASSO)

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ClinicalTrials.gov Identifier: NCT01391325
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Brief Summary:
This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for each patient.

Condition or disease Intervention/treatment Phase
Gout Drug: Allopurinol Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1735 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Allopurinol Safety Study Evaluating Outcomes in Gout Patients (LASSO)
Study Start Date : July 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Allopurinol
Treatment.
Drug: Allopurinol
Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.




Primary Outcome Measures :
  1. Safety of Allopurinol [ Time Frame: Every month for 6 months. ]
    Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.


Secondary Outcome Measures :
  1. Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL [ Time Frame: Month 6 ]
    Proportion of subjects with serum urate (sUA) less than 6.0 mg/dL at Month 6 using Last Observation Carried Forward (LOCF) for subjects with missing values at Month 6.

  2. Incidence of Gout Flares [ Time Frame: Every month for 6 months. ]
    Proportion of subjects who experienced at least one gout flare requiring treatment during the study.

  3. Mean Change From Baseline to Month 6 in SF-36 PCS+MCS [ Time Frame: Month 6 ]
    The SF-36 is a short-form health survey with 36 questions that yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental health (MCS) summary. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability. The component scores (PCS and MCS) are norm-based to a standard population with a mean of 50 and a standard deviation of 10.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets the diagnosis of gout according to the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
  • Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening.
  • If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening.
  • Must have had at least 2 gout flares in the past year.

Exclusion Criteria:

  • Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
  • History or suspicion of drug abuse.
  • History of autoimmune disease requiring systemic treatment.
  • Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or hepatitis B antibody (HBsAg) infection.
  • History of malignancy within the previous 5 years (with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer).
  • Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure, or stroke within the last 12 months.
  • Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure above 95 mm Hg).
  • Estimated creatinine clearance < 30 mL/min by Cockcroft-Gault formula.
  • Kidney or other organ transplant.
  • Active peptic ulcer disease requiring treatment.
  • History of xanthinuria, active liver disease, or hepatic dysfunction.
  • If unable to take gout flare prophylaxis of either colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal function, use of contraindicated medications).
  • Known hypersensitivity or allergy to allopurinol.

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): NCT01391325


  Show 173 Study Locations
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
Study Director: S Baumgartner, MD Ardea Biosciences, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01391325     History of Changes
Other Study ID Numbers: ALLO-401
First Posted: July 12, 2011    Key Record Dates
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs