Allopurinol Outcome Study (LASSO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01391325|
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gout||Drug: Allopurinol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1735 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
- 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.
- 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.
- 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.
- 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.
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
|Study Director:||S Baumgartner, MD||Ardea Biosciences, Inc.|