Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
230
Trial Sponsor
Clinical Trial Start Date
2008
0Primary Completion Date
2009
0Study Completion Date
2009
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Interventional Trial Phase
Phase 20
Official Name
A Phase 2 Study of Stem-Cell-Mobilization in Subjects With Diabetic Neuropathy Receiving SB-5090
Last Updated
November 1, 2012
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Single0
Masked Party
Participant0
Other attributes
Intervention Treatment
Placebo0
SB-5090
Study summary
The primary and secondary objectives of this study are: Primary: To evaluate stem-cell-mobilization in subjects with diabetic neuropathy receiving SB-509. Stem cell mobilization will be assessed by evaluating the presence of stem cells circulating in peripheral blood. Secondary: To evaluate the safety of SB-509 in subjects treated with SB-509 with diabetic neuropathy; and to compare the effect of SB-509 versus placebo on a pre-defined multi-endpoint analysis that includes visual analog scale for pain intensity (VASPI), total neuropathy score (TNS), evoked nerve conduction velocity (NCV) and quantitative sensory testing (QST)
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