Study of Levotofisopam 50 mg Three Times a Day (TID) Administered for 7 Days on Hyperuricemia and Gout
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|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.
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): NCT01519687
|Contact: John S. Sundy, MD, PhD||(919) email@example.com|
|Contact: Lou Cappoli, MBA||(919) firstname.lastname@example.org|
|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 email@example.com|
|Contact: Lou Cappoli (919) 684-4888 firstname.lastname@example.org|
|Principal Investigator: John S. Sundy, MD, PhD|
|Sub-Investigator: Robert Noveck, MD, PhD|
|Principal Investigator:||John S. Sundy, MD, PhD||Duke Clinical Research Unit|