Allopurinol Outcome Study

Gout Clinical Trial

— LASSO  

Official title:

Long-term Allopurinol Safety Study Evaluating Outcomes in Gout Patients (LASSO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391325
• Other study ID #: ALLO-401
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2011
• Last updated: May 16, 2014
• Start date: July 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2014
• Source: Ardea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardBelgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesNew Zealand: Health and Disability Ethics CommitteesNew Zealand: MedsafeAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteeSouth Africa: Human Research Ethics CommitteeSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1735
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ardea Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  New Zealand,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Allopurinol	Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.	Every month for 6 months.	Yes
Secondary	Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL	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.	Month 6	No
Secondary	Incidence of Gout Flares	Proportion of subjects who experienced at least one gout flare requiring treatment during the study.	Every month for 6 months.	No
Secondary	Mean Change From Baseline to Month 6 in SF-36 PCS+MCS	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.	Month 6	No