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

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 3

Conditions

Diabetic Neuropathies

Treatments

Drug: tramadol, acetaminophen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00210847

CR004660

Details and patient eligibility

About

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.

Full description

Previous studies have shown that tramadol HCl is effective in painful diabetic neuropathy. The treatment of neuropathic pain often requires the use of more than one medication, working through different mechanisms of action, to provide the best pain relief. 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. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. Patients who experience painful diabetic neuropathy will be enrolled. There will be a period of up to 3 weeks during which patients will stop taking medications not allowed by the study. A 7-day baseline period will follow, during which time patients will call into an Interactive Voice Response (IVR) system every night at bedtime to record daily assessments including average daily pain and sleep interference. Patients who enter the double-blind portion of the study will be randomized (like with the toss of a coin) to receive either tramadol HCl/acetaminophen or placebo. The dose of tramadol HCl/acetaminophen or placebo will be gradually increased until the doctor determines the patient is taking an adequate dose; up to 1 or 2 tablets 4 times per day, but not more than 8 tablets per day. Every night at bedtime during the double-blind phase, patients will call the IVR system to report assessments of average daily pain, sleep interference and the number of tablets of study medication taken that day. At the end of the study, patients will be tapered off their study medication. The objective of this study is to compare the analgesic effectiveness and safety of tramadol HCl/acetaminophen versus placebo for the treatment of painful diabetic neuropathy.

1 or 2 tramadol HCl (37.5 milligrams)/acetaminophen (325 milligrams) combination tablets or matching placebo by mouth up to 4 times a day for 66 days

Enrollment

313 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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