Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, double-blind, study to evaluate the analgesic efficacy and safety of
      Dexketoprofen trometamol and Tramadol hydrochloride combination versus placebo on moderate to
      severe acute pain in patients with acute low back pain.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, double-dummy, parallel group,
      placebo-controlled study encompassing 2 study phases: a single-dose phase (first 8 hours) and
      a multiple-dose phase starting after the single-dose phase (from 8h until day 5).

      Study population will be of male or female patients aged 18 years to 65 years with acute low
      back pain of moderate to severe intensity, whose onset of the current acute low back pain
      episode is within 48 hours prior to Screening. Patients with or without radiculopathy will be
      included, excluding those with neurological signs, according to the Quebec Task Force
      classification. Patients experiencing a new episode of low back pain will be eligible only if
      preceded by a period of at least 2 months without any low back pain. Patients should be free
      from analgesic due to previously administered pain killer (immediate or slow release
      formulations), according to exclusion criteria.

      Approximately 612 patients will be screened to achieve 510 patients randomly assigned to
      study treatment.

      In the single-dose phase patients will receive a single-dose treatment, consisting of 1
      film-coated tablet and 2 capsules which have to be orally administered together at the same
      time (Day 1). The multiple-dose phase will begin 8 hours after the first dose. The patients
      assigned to DKP.TRIS/TRAM.HCl fixed combination or TRAM.HCL 100 mg during the single-dose
      phase will continue to receive the same treatment during the multiple-dose phase; however,
      the patients assigned to receive placebo during the single-dose phase will either receive
      DKP.TRIS/TRAM.HCl fixed combination or TRAM.HCL 100 mg during the multiple-dose phase.
    

Intervention name(s): Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 MG; Tramadol Hydrochloride 100 MG; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered as one single tablet to be taken every 8 hours; Administered as two capsules with 50 mg each to be taken every 8 hours; Administered as one tablet if matching Dexketoprofen Trometamol 25 mg and Tramadol Hydrochloride 75 MG or two capsules if matching Tramadol Hydrochloride 100 MG
Other intervention name(s): Skudexa; Tramadol
Intervention MeSH terms: Dexketoprofen trometamol; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 study phases: a single-dose phase (first 8 hours) and a multiple-dose phase starting after the single-dose phase (from 8h until Day 5).In the single-dose phase the patients will receive a single dose treatment, consisting of 1 film-coated tablet and 2 capsules which must be orally administered together at the same time (Day 1). The multiple-dose phase will begin 8 hours after the first dose. The patients assigned to DKP.TRIS/TRAM.HCl fixed combination or TRAM.HCL 100 mg during the single-dose phase will continue to receive the same treatment during the multiple-dose phase; however, the patients assigned to receive placebo during the single-dose phase will either receive DKP.TRIS/TRAM.HCl fixed combination or TRAM.HCL 100 mg during the multiple-dose phase.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment