A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy

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

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Criteria

Inclusion Criteria:

• Males and females, age 18 to 75

• If female, must be of non-childbearing potential or practicing birth control

• Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy

• Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months

• Must be willing to washout of all analgesic medications prior to entry into the study

Exclusion Criteria:

• Has other conditions that may cause pain

• Currently receiving analgesic medications for conditions other than diabetic neuropathic pain

• Has a history of certain psychiatric diseases

• Has a history of certain heart or cardiovascular conditions

• Has any clinically significant recent infection, injury, or illness

• Current participation in another clinical study or participation within the past 30 days

• Is incapacitated, bedridden or confined to a wheelchair

• Is pregnant and/or breastfeeding

• Previous participation in this study or any other study with this investigational product.