A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients
Condition: Diabetic Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 3

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.
    

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
    

Intervention name(s): tramadol, acetaminophen
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: peripheral neuropathy; Diabetic neuropathy; pain; diabetes; extremities; neuropathy; diabetic