A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study Evaluating the Analgesic Efficacy and Safety of Intravenous CR845 in Patients Undergoing Abdominal Surgery

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study Evaluating the Analgesic Efficacy and Safety of Intravenous CR845 in Patients Undergoing Abdominal Surgery

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 03 Aug 2017

At a glance

  • Drugs Difelikefalin (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Cara Therapeutics
  • Most Recent Events

    • 03 Aug 2017 According to a Cara Therapeutics media release, completion of enrolment in this trial is expected in the fourth quarter of 2017.
    • 21 Jun 2017 According to a Cara Therapeutics media release, a prespecified interim conditional power analysis of this trial has been completed and based on the guidance of the Independent Data Monitoring Committee (IDMC), trial will continue to test two doses of CR845 (1.0, and 0.5 µg/kg I.V.) .
    • 24 Apr 2017 According to a Cara Therapeutics media release, an interim conditional power assessment at approximately 65 percent patient recruitment completion will read out in the second quarter of 2017.
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