Open-label, randomised, controlled, parallel group study for the evaluation of safety and efficacy of Diclofenac HPBCD 75 mg ampoules s.c. in comparison with Diclofenac HPBCD 75 mg ampoules i.m. and Voltaren 75 mg ampoules i.m. in the treatment of acute moderate to severe pain following minor orthopaedic surgery.

Trial Profile

Open-label, randomised, controlled, parallel group study for the evaluation of safety and efficacy of Diclofenac HPBCD 75 mg ampoules s.c. in comparison with Diclofenac HPBCD 75 mg ampoules i.m. and Voltaren 75 mg ampoules i.m. in the treatment of acute moderate to severe pain following minor orthopaedic surgery.

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Feb 2016

At a glance

  • Drugs Diclofenac (Primary)
  • Indications Postoperative pain
  • Focus Adverse reactions
  • Acronyms DIRECT
  • Sponsors IBSA
  • Most Recent Events

    • 22 Mar 2013 New source identified and integrated (ISRCTN: Current Controlled Trials; 78851459).
    • 02 Aug 2011 New trial record
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