An exploratory, randomized, double blind, placebo controlled, parallel groups Phase II clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route, as part of an analgesic therapy balanced with morphine, followed by an open label extension, in the treatment of post-operative pain due to abdominal hysterectomy.

Trial Profile

An exploratory, randomized, double blind, placebo controlled, parallel groups Phase II clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route, as part of an analgesic therapy balanced with morphine, followed by an open label extension, in the treatment of post-operative pain due to abdominal hysterectomy.

Completed
Phase of Trial: Phase II

Latest Information Update: 30 Sep 2016

At a glance

  • Drugs E 52862 (Primary)
  • Indications Postoperative pain
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Laboratorios Dr. Esteve
  • Most Recent Events

    • 30 Sep 2016 Primary endpoint (total morphine consumption in mg administered by PCA during the 24 hours post-operative period) has not been met, according to results presented at the 16th World Congress on Pain.
    • 30 Sep 2016 Status changed from recruiting to completed, according to results presented at the 16th World Congress on Pain.
    • 30 Sep 2016 Results of this study, presented at the 16th World Congress on Pain.
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