Study of Levotofisopam 50 mg Three Times a Day (TID) Administered for 7 Days on Hyperuricemia and Gout
|ClinicalTrials.gov Identifier: NCT01519687|
Recruitment Status : Unknown
Verified January 2012 by Pharmos.
Recruitment status was: Recruiting
First Posted : January 27, 2012
Last Update Posted : January 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hyperuricemia Gout||Drug: levotofisopam||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Inpatient Study of Levotofisopam 50 mg TID Administered for 7 Days to Men and Postmenopausal Women With Hyperuricemia and Gout|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2012|
All patients will receive a single dose of 50 mg on Day 1, 50 mg three times a day (TID) on Days 2 through 6, and a single dose of 50 mg on Day 7. Each dose of study drug will be administered by authorized site personnel throughout the 7-day inpatient treatment period.
50 mg on Day 1, 50 mg TID on Days 2 through 6, and a single dose of 50 mg on Day 7
Other Name: S-tofisopam
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519687
|Contact: John S. Sundy, MD, PhD||(919) firstname.lastname@example.org|
|Contact: Lou Cappoli, MBA||(919) email@example.com|
|United States, North Carolina|
|Duke Clinical Research Unit (DCRU)||Recruiting|
|Durham, North Carolina, United States, 27720|
|Contact: John S. Sundy, MD, PhD 919-684-2347 firstname.lastname@example.org|
|Contact: Lou Cappoli (919) 684-4888 email@example.com|
|Principal Investigator: John S. Sundy, MD, PhD|
|Sub-Investigator: Robert Noveck, MD, PhD|
|Principal Investigator:||John S. Sundy, MD, PhD||Duke Clinical Research Unit|