A Randomized, Blinded, Inpatient Study to Investigate the Pharmacokinetics, Relative Bioavailability and Safety of 2 Doses of the XaraColl Bupivacaine Collagen Implant (200 and 300 mg Bupivacaine Hydrochloride) Compared to Bupivacaine Hydrochloride Infiltration (150 mg) After Open Laparotomy Hernioplasty

Trial Profile

A Randomized, Blinded, Inpatient Study to Investigate the Pharmacokinetics, Relative Bioavailability and Safety of 2 Doses of the XaraColl Bupivacaine Collagen Implant (200 and 300 mg Bupivacaine Hydrochloride) Compared to Bupivacaine Hydrochloride Infiltration (150 mg) After Open Laparotomy Hernioplasty

Completed
Phase of Trial: Phase III

Latest Information Update: 25 May 2015

At a glance

  • Drugs Bupivacaine (Primary) ; Bupivacaine
  • Indications Postoperative pain
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Innocoll
  • Most Recent Events

    • 14 May 2015 Status changed from active, no longer recruiting to completed, per Innocoll AG media release.
    • 01 Apr 2015 Top-line results published in Innocoll media release support a dose selection of 300mg for phase III trials.
    • 12 Mar 2015 Planned End Date changed from 1 Mar 2015 to 1 Apr 2015 as reported by ClinicalTrials.gov record.
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