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

NCT00210847 | Completed Phase 3

• 1 other identifier: CR004660
• Study Type: interventional
• Target: 313
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetic Neuropathies

Keywords

peripheral neuropathy; Diabetic neuropathy; pain; diabetes; extremities; neuropathy; diabetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

tramadol, acetaminophen DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• PriCara, Unit of Ortho-McNeil, Inc.: collaborator

Related Publications (1)

• 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. doi: 10.1185/030079906X162674.

  PMID: 17257476 RESULT

Related Links

• 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

MeSH Terms

Conditions

Diabetic Neuropathies; Peripheral Nervous System Diseases; Pain; Diabetes Mellitus

Interventions

Ultracet

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: December 1, 2003
• Study Completion: May 1, 2005
• Last Updated: June 10, 2011

Record last verified: 2010-04