Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Ac… (NCT02063997) | Clinical Trial Compass
CompletedPhase 2
Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients
United States248 participantsStarted 2014-03
Plain-language summary
The purpose of this study is to determine whether arhalofenate is effective in preventing flares and reducing serum uric acid in gout patients.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Male or female patients between 18 and 75 years of age, inclusive
* Known gout diagnosis (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout, see Appendix 3)
* At least three patient-reported and documented flares during the 12 months prior to screening (the first of these flares may have resulted in the gout diagnosis; any recent flare must have resolved, with the patient back to usual comfort level at least seven days prior to screening)
* Have not used any ULT since at least two weeks prior to screening
* Have not used colchicine since at least two weeks prior to screening
* Usual level of resting pain when NOT experiencing flare is three or less on an 11-point numerical rating scale (NRS)
* Have a sUA ≥ 7.5 mg/dL and ≤ 12 mg/dL at screening
* All female patients must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses for at least two years); or have a partner who has undergone vasectomy or must agree to use two medically accepted methods of contraception including a barrier method (see Appendix 4) for the entire duration of study participation unless she reports complete sexual abstinence. Female patients must not be pregnant or lactating
* Estimated creatinine clearance (eCrCl) ≥ 60 ml/min/1.73m2 calculated by Cockcroft-Gault method at screening
* Liver function tests ≤ 3X ULN for AST, ALT and total bilirubin; ≤ 3X ULN for ALP and GGT; and ≤ 3X …
What they're measuring
1
The incidence of flares (mean number of flares per patient) from baseline through Week 12 in the arhalofenate 800 mg group compared to the allopurinol 300 mg group.