A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of neuropathic pain often requires the use of more than one medication. The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. Patients who experience painful diabetic neuropathy will be enrolled in this study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Acetaminophen; Tramadol

Criteria

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 at least 5 on scale of 11)

• In generally good health

• If female of childbearing potential, using acceptable method of birth control

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