GW274150
Drug60 mg /day
NCT Number: NCT00379990
This is an exploratory study to examine the effect of iNOS inhibition in rheumatoid arthritis patients. The study involves 28 days repeat dosing with GW274150 (dose determined by the results from a previous study), prednisolone (7.5mg) or placebo.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
GSK Investigational Site, Belgrade, Serbia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
60 mg /day
7.5 mg/day
Placebo
Time frame: Day 1, Day 15 and Day 28
Power Doppler ultrasonographic measurement of synovial vascularity
Time frame: Day 1, 15 and 28
High frequency ultrasound measurement of synovial thickness
Time frame: Day 1, 15 and 28
12-lead ECG meaurements
Time frame: Day 1, 15 and 28
Blood pressure and heart rate
Time frame: Day 1, 8, 15, 22, 28 and Follow Up
Laboratory assessments including liver function tests, amylase and lipase
Time frame: Day 15 and Day 28
Maximum plasma concentration of GW274150
Time frame: Days 8,15 and Day 28
Trough plasma concentration of GW274150
Time frame: Day 1 to Day 28 and Follow Up
Adverse events
GlaxoSmithKline
Industry
A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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