The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months
Film coated tablets (0 mg esreboxetine), once daily for 6 months
Change from baseline to 3 and 6 months in the mean daily pain rating score measured by the 11 point pain intensity Numerical Rating Scale (NRS).
Time frame: 6 months
Change from baseline to 3 and 6 months in the FIQ-Total score
Time frame: 6 months
Pain (including other measures of daily pain and responder analyses);
Time frame: 6 months
Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36);
Time frame: 6 months
Global efficacy measures PGIC);
Time frame: 6 months
Sleep (MOS);
Time frame: 6 months
Work productivity;
Time frame: 6 months
Depression (HADS)
Time frame: 6 months
Safety (vital signs, ECG, laboratory, suicidal ideation)
Time frame: 6 months
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