This is a trial to investigate the effectiveness and safety of \[S,S\]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of \[S,S\]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
330
Oral tablet once a day dosing for 10 weeks.
Oral tablet once a day dosing for 10 weeks.
Change from baseline in weekly average pain score
Time frame: 8 weeks
Responder rates (patients with a 30% reduction from baseline in weekly average pain score and patients with a 50% reduction from baseline in weekly average pain score)
Time frame: 8 weeks
Change from baseline in weekly average sleep interference scale
Time frame: 8 weeks
Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory
Time frame: 8 weeks
Modified Brief Pain Inventory-Short Form
Time frame: 8 weeks
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Pfizer Investigational Site
Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Mission Viejo, California, United States
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Denver, Colorado, United States
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New Britain, Connecticut, United States
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Waterbury, Connecticut, United States
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Tampa, Florida, United States
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Winter Haven, Florida, United States
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Lexington, Kentucky, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
...and 46 more locations