A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)

Phase 2

Withdrawn

Brief Summary: The purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy.

Recruitment & Eligibility

Inclusion Criteria

Patient has been treated for type 1 or 2 diabetes mellitus with glycosylated hemoglobin
Patient has pain in both feet that occurred after onset of diabetes
Patient agrees to maintain a consistent activity level throughout the study
Patient is not on chronic pain therapy, or is on a stable dose of one pain therapy
Female patients of reproductive potential must agree to use two acceptable methods of birth control through out the study
Patients taking a pain medication must be on a stable dose at least 1 month prior to participating in study

Exclusion Criteria

Patient has a history of congestive heart failure
Patient has/had a seizure disorder
Patient has tried and failed 3 or more drugs to treat neuropathic pain
Patient is currently taking pregabalin or duloxetine hydrochloride
Patient has had a malignancy within the past 2 years (excluding basal cell carcinoma)
Patient has history of hepatitis B or C or HIV infection
Patient has skin-condition that may decrease sensitivity in area of neuropathic pain

Primary Outcome Measures

Name	Time	Method
analgesic efficacy measured by patients self reported pain level after single dose administration	5-11 hours after single dose is administered

Secondary Outcome Measures

Name	Time	Method
The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo	24 hours after single dose is administered

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