Clinical Trial: Study of Levotofisopam 50 mg Three Times a Day (TID) Administered for 7 Days on Hyperuricemia and Gout

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Open-Label, Inpatient Study of Levotofisopam 50 mg TID Administered for 7 Days to Men and Postmenopausal Women With Hyperuricemia and Gout

Brief Summary: The purpose of this study is to determine whether levotofisopam is safe and effective in the treatment of hyperuricemia and gout.

Detailed Summary: The primary objectives of this study are (1) to evaluate the safety and tolerability of levotofisopam in patients with hyperuricemia and gout, and (2) to evaluate the effect of treatment with levotofisopam on serum urate levels in these patients.
Sponsor: Pharmos

Current Primary Outcome: Percentage reduction in serum urate [ Time Frame: Days 1-7 ]

The primary efficacy variable is the percentage reduction in serum urate from baseline to Day 7 on treatment with levotofisopam.


Original Primary Outcome: Same as current

Current Secondary Outcome: Absolute reduction in serum urate from baseline [ Time Frame: Days 1-7 ]

Secondary efficacy variables include absolute reduction in serum urate from baseline to Day 7 on treatment with levotofisopam, proportion of subjects with serum urate < 6 mg/dL on Day 7, change in fractional excretion of urate from baseline to Day 6, and change in 24-hour urinary uric acid from baseline to Day 6.


Original Secondary Outcome: Same as current

Information By: Pharmos

Dates:
Date Received: January 24, 2012
Date Started: January 2012
Date Completion: June 2012
Last Updated: January 26, 2012
Last Verified: January 2012