Phase
Condition
Neurologic Disorders
Treatment
N/AClinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of diabetic neuropathy in both lower extremities
Lower extremity pain for at least 3 months
Stable treatment of diabetes with drugs or diet for at least 3 months
Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of <10%)
Documented daily pain on at least 4 of 7 days during baseline period (pain rated atleast 5 on scale of 11)
In generally good health
If female of childbearing potential, using acceptable method of birth control
Exclusion
Exclusion Criteria:
No failed trials of tramadol HCl or tramadol HCl/acetaminophen
No participation in more than 2 clinical trials for treatment of neuropathic pain
No more than 2 failed trials of medications for neuropathic pain
No use of prohibited concomitant medications
No peripheral neuropathy caused by condition other than diabetes
No other pain more severe than neuropathic pain
No progressive or degenerative neurological disorder
No painful peripheral diabetic neuropathy for > 10 years
No kidney or liver dysfunction
Not pregnant or breast-feeding
No unstable medical disease
No clinically significant medical conditions
No condition that might affect the way the body absorbs or processes the study drug
No history of suicide attempt/tendencies
No major psychiatric disorder in past 6 months
No history of drug or alcohol abuse/dependance in the past 2 years
No amputations
No active infection of the lower extremity
No active foot ulcer
No use of an investigational drug in past 30 days