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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This is a double blind (a medical research study in which neither the researchers nor the
      participants know what treatment the participants is receiving), randomized (study drug is
      assigned by chance), placebo-controlled, parallel group (a medical research study comparing
      the response in 2 or more groups of participants receiving different interventions
      [treatments]) and up-titration study in participants with chronic low back pain. The study
      will consist of 6 visits (Day -7 to Day -1 [Visit 1], Day 1 [Visit 2], Day 3 [telephone
      visit], Day 8 [Visit 3], Day 15 [Visit 4] and Day 29 [Visit 5]) and 2 phases: a screening
      phase and treatment phase. Screening phase will be of 7 days during which, participants will
      receive stable dose of non-steroidal anti-inflammatory drugs (NSAIDS) or COX-2 selective
      inhibitors (NSAID that specifically inhibits an enzyme known as cyclooxygenase-2) for pain
      therapy. On the basis of average pain intensity over the last 48 hours which will be measured
      at baseline (at the end of screening period), participants will enter the treatment phase.
      Treatment phase will be of 28 days which includes 7-days of dose titration period. In
      treatment phase all participants will be randomly assigned to 1 of 2 possible treatments:
      tramadol HCl 75 milligram (mg)/acetaminophen 650 mg ER tablet treatment or the equivalent
      placebo (an inactive substance) treatment until study completion, Day 29. Participants will
      receive 1 tablet of tramadol HCl/acetaminophen ER or its equivalent placebo, once daily for 3
      days. After the first 3 days, the participants will receive a telephone inquiry monitoring
      the occurrence of adverse events and will be given additional administration instructions for
      the next 4 days (1 tablet twice daily for 4 days). From Day 7, participants will receive 1 or
      2 tablets twice a day depending on the degree of pain relief required. Participants will
      visit the center on the Day 8 (Visit 3), Day 15 (Visit 4), and Day 29 (Visit 5) after
      starting study drug. The efficacy will be assessed by measuring extent of reduction in pain
      intensity on a Visual Analog Scale (VAS). Participants' safety will be monitored throughout
      the study.
    

Intervention name(s): Tramadol HCl/acetaminophen Extended Release; Placebo; Tramadol HCl/acetaminophen Extended Release; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Ultracet Extended Relaese; Ultracet Extended Relaese
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic low back pain; Tramadol Hydrochloride (HCl); acetaminophen