A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Reboxetine

Criteria

Inclusion Criteria:

• Male or female of any race at least 18 years of age

• Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year

• Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale

Exclusion Criteria:

• Patients with significant hepatic impairment

• Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain

• Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy

• Amputations other than toes

• A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression

• History of transient ischemic attack or stroke

• Myocardial infarction or unstable angina within the past three months