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

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00210847

Purpose

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.

Condition	Intervention	Phase
Diabetic Neuropathies	Drug: tramadol, acetaminophen	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen for the Treatment of Painful Diabetic Neuropathy

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Tramadol Tramadol hydrochloride Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Change in the average of daily pain score recorded in the IVR system from baseline to the patient's final week of treatment with study medication.

Secondary Outcome Measures:

Efficacy measured by Brief Pain Inventory, Visual Analogue Scale, Short-Form McGill Pain Questionnaire, Profile of Mood States, SF-36 Health Survey, Physician and Subject Global Impression of Change, average daily sleep interference

Enrollment:	313
Study Start Date:	December 2003
Study Completion Date:	May 2005

Detailed 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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210847

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

PriCara, Unit of Ortho-McNeil, Inc.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Additional Information:

Clinical Study Report: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen for the Treatment of Painful Diabetic Neuropathy This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Freeman R, Raskin P, Hewitt DJ, Vorsanger GJ, Jordan DM, Xiang J, Rosenthal NR; CAPSS-237 Study Group. Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy. Curr Med Res Opin. 2007 Jan;23(1):147-61.

Study ID Numbers:	CR004660
Study First Received:	September 13, 2005
Last Updated:	May 21, 2009
ClinicalTrials.gov Identifier:	NCT00210847 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

peripheral neuropathy
Diabetic neuropathy
pain
diabetes

extremities
neuropathy
diabetic

Study placed in the following topic categories:

Diabetic Neuropathies
Tramadol
Diabetes Mellitus
Central Nervous System Depressants
Endocrine System Diseases
Narcotics
Pain
Neuromuscular Diseases

Analgesics, Non-Narcotic
Peripheral Nervous System Diseases
Endocrinopathy
Analgesics
Peripheral Nervous System Agents
Analgesics, Opioid
Diabetes Complications
Acetaminophen

Additional relevant MeSH terms:

Diabetic Neuropathies
Tramadol
Physiological Effects of Drugs
Nervous System Diseases
Diabetes Mellitus
Central Nervous System Depressants
Endocrine System Diseases
Narcotics
Pharmacologic Actions
Neuromuscular Diseases

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Diseases
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid
Diabetes Complications
Acetaminophen

ClinicalTrials.gov processed this record on September 02, 2009