A randomized, double-blind, controlled with active treatment (tramadol 100 mg) and placebo, parallel groups, Phase II clinical trial to establish the effective dose between 4 strengths of E-58425 for moderate to severe dental pain [Ensayo clínico de fase II aleatorizado, doble ciego, controlado con tratamiento activo (tramadol 100 mg) y placebo, de grupos paralelos, para establecer la dosis eficaz de entre 4 concentraciones de E-58425 para dolor dental de moderado a intenso]

Trial Profile

A randomized, double-blind, controlled with active treatment (tramadol 100 mg) and placebo, parallel groups, Phase II clinical trial to establish the effective dose between 4 strengths of E-58425 for moderate to severe dental pain [Ensayo clínico de fase II aleatorizado, doble ciego, controlado con tratamiento activo (tramadol 100 mg) y placebo, de grupos paralelos, para establecer la dosis eficaz de entre 4 concentraciones de E-58425 para dolor dental de moderado a intenso]

Completed
Phase of Trial: Phase II

Latest Information Update: 20 Nov 2016

At a glance

  • Drugs Celecoxib/tramadol (Primary) ; Tramadol
  • Indications Dental pain; Postoperative pain
  • Focus Therapeutic Use
  • Sponsors Laboratorios Dr. Esteve
  • Most Recent Events

    • 30 Sep 2016 Results (n=334) assessing efficacy and safety presented at the 16th World Congress on Pai.
    • 16 Oct 2013 Primary endpoint 'Sum-of-pain-intensity-difference' has been met. as reported by an Esteve media release.
    • 15 Oct 2013 Top-line results published in an Esteve media release.
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