An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Tramadol HCl/acetaminophen Extended Release; Placebo; Tramadol HCl/acetaminophen Extended Release; Placebo
Intervention description: Participants will receive 1 tablet containing 75 mg of tramadol HCl and 650 mg of acetaminophen, once daily on Days 1to 3, then 1 tablet twice daily on Days 4 to 7; Participants will receive 1 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 4 to 7; Participants will receive 1 or 2 tablets containing 75 mg of tramadol HCl and 650 mg of acetaminophen, twice daily on Days 8 to 28; Prticipants will receive 1 or 2 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 8 to 28
Intervention MeSH terms: Acetaminophen; Tramadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 248.0
Sex: All
Minimum age: 25 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic low back pain; Tramadol Hydrochloride (HCl); acetaminophen

Summary:

      The purpose of this study is to evaluate the efficacy and safety of extended release (ER)
      tramadol hydrochloride (HCl)/acetaminophen compared with placebo in participants with chronic
      (lasting a long time) low-back pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed with low back pain at least 3 months before the screening or
             washout period

          -  Participants who have taken a stable dose of Non-Steroidal Anti-Inflammatory Drugs
             (NSAIDs) (drugs used for reducing inflammation and pain ) or Cyclo-Oxygenase 2 (COX-2)
             selective inhibitors (an anti-inflammatory drug that fights pain) from 7 days before
             investigational product administration, and could maintain the same dose during the
             period of the study

          -  Participants whose average pain intensity is more than or equal to 4.0 centimeters on
             Visual Analog Scale over the last 48 hours after the completion of screening

          -  Postmenopausal or surgically sterile or abstinent women or practicing a highly
             effective method of birth control

          -  Women with childbearing potential must have negative pregnancy test

        Exclusion Criteria:

          -  Participants who have taken tramadol or tramadol HCl or acetaminophen, or narcotic
             (strong habit-forming drug that stops pain and depresses the central nervous system)
             analgesic tablet within 30 days before investigational product administration

          -  Participants who have taken acetaminophen tablet within 7 days before investigational
             product administration

          -  Participants with tumor or infection in meninges or spinal cord

          -  Participants who have fibromyalgia (neurosensory disorder characterized by muscle
             pain, joint stiffness, and fatigue), reflex sympathetic dystrophy (feeling of pain
             associated with evidence of minor nerve injury) or causalgia (persistent, severe
             burning sensation of the skin), acute spinal cord compression, acute nerve root
             compression, severe lower extremity weakness or numbness, regional pain syndrome,
             meningitis (inflammation of the meninges), diskitis (nonbacterial inflammation of an
             intervertebral disk or disk space), back pain because of secondary infection or tumor,
             or pain caused by a confirmed or suspected neoplasm

          -  Participants who have taken analgesic (including local agents or anesthetics),
             sedative-hypnotic (e.g., diazepam), or muscle relaxant other than a stable dose of
             NSAIDs or COX-2 selective inhibitors within 5 times the half-life of the concerned
             agent before investigational product administration