A Study Comparing the Effectiveness and Safety of Extended-release Tramadol Versus Placebo in the Treatment of Chronic Low Back Pain
Condition: Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the analgesic efficacy of oral, once-daily tramadol
      ER 300 mg and 200 mg to placebo in patients with moderate to severe chronic low back pain
      requiring daily analgesic treatment. The study hypothesis is that tramadol ER is effective in
      the treatment of moderate to severe chronic low back pain.
    

Detailed description: 
      Immediate release (IR) tramadol has demonstrated efficacy in several pain conditions
      including: obstetrical, gynecological, orthopedic, abdominal, and oral surgery. The short
      elimination half-life of IR tramadol necessitates every 4-6 hour dosing in order to maintain
      optimum levels of analgesia in chronic pain. The study medication in this study is a
      once-daily, extended release (ER) tramadol formulation. This is a multicenter, double-blind,
      randomized, placebo-controlled, parallel-group study. At the Screening Visit, patients
      eligible for study participation by medical history, physical exam and other evaluations will
      enter a 2-7 day washout period during which time analgesics will not be allowed. At Visit 2,
      patients with a pain intensity >= 40 mm on a 100 mm visual analog scale (VAS) and who meet
      all other eligibility criteria will be admitted into a 3-week, open-label, run-in period
      during which time they will receive tramadol ER 100 mg once daily (QD) for at least 3 days.
      On Day 4, the dose will be increased to tramadol ER 200 mg QD, based on tolerability.
      Patients must be maintained on a minimum dose of tramadol 200 mg QD by the beginning of
      Week-2 (Visit 3); the dose may be increased to tramadol ER 300 mg QD at Visit 3, based on
      tolerability. Patients must increase their tramadol ER dose to 300 QD by the beginning of
      Week - 1 (Visit 4); this dose must be maintained for one week. Patients with pain
      unresponsive to appropriate dose adjustments or with unacceptable side effects will be
      discontinued from the study and an alternative analgesic therapy will be initiated. Patients
      receiving tramadol ER 300 mg QD at the end of the run-in period (Visit 5, Week 0) will enter
      a 12-week, double-blind period during which they will be randomized to receive tramadol ER
      300 mg, tramadol ER 200 mg, or placebo QD. No dose adjustments will be permitted during the
      double-blind period of the study. Patients will return for safety and efficacy evaluations at
      Weeks 1, 2, 4, 8 and 12 or early termination. Study medication will be discontinued at Week
      12 and patients will return after one week for a post-treatment visit (Week 13).
    

Intervention name(s): Tramadol HCl ER
Intervention type(s): Drug
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: chronic low back pain; chronic pain; low back pain; extended-release analgesia; opioid