Status:
TERMINATED
Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.
Lead Sponsor:
Pfizer
Conditions:
Gout
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid in subjects suffering from gout following 14 days of dosing, as well as assessing safety and tolerability.
Eligibility Criteria
Inclusion
- Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of acute Arthritis of Primary Gout.
- Subjects taking urate lowering therapy at the time of screening must be willing to discontinue their prior urate lowering therapy from the time of Screening Visit 1 until completion of the study period Day 16.
- Subjects taking urate lowering therapy at the time of screening must have a serum urate level of \>= 8.0 mg/dL at time of the second screening visit.
- Subjects NOT taking urate lowering therapy at the time of screening must have a serum urate level of \>= 8.0 mg/dL at both screening visits 1 and 2.
Exclusion
- Positive medical history or current evidence of medical or psychiatric condition/disease, or ECG or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- Chronic kidney disease classified as moderate or severe (Clinical Practice Guideline, National Kidney Foundation)12; with GFR \< 60 mL/min/1.73m2 calculated by the Cockcroft-Gault equation.
- Subjects with current tophaceous gout.
- Gout flare that has not resolved for at least 2 weeks prior to randomization.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02187029
Start Date
July 1 2014
End Date
December 1 2014
Last Update
November 11 2016
Active Locations (4)
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1
MRA Clinical Research, LLC
Miami, Florida, United States, 33143
2
Miami Research Associates, Inc.
South Miami, Florida, United States, 33143
3
Vince and Associates Clinical Research Inc.
Overland Park, Kansas, United States, 66211
4
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66212