Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Completed
Premier Research Group plc
Phase 2
2014-10-20
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy
hernioplasty and assess the relative bioavailability of Xaracoll compared to a local
bupivacaine infiltration.
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Completed
Innocoll
Phase 2
2014-10-20
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy
hernioplasty and assess the relative bioavailability of Xaracoll compared to a local
bupivacaine infiltration.
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
Completed
Innocoll
Phase 3
2015-08-01
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled
efficacy and safety study of postoperative pain in adults who are scheduled for unilateral
inguinal hernioplasty via open laparotomy (tension-free technique).
Patients will assess their postoperative pain intensity (PI) using an 11-point numerical
rating scale (NRS) from 0 hour through 72 hours postoperatively.
The expected maximum study duration for each patient will be up to 60 days, including a
maximum 30-day screening period, the day of surgery and implantation, and a 30-day post
implantation period including treatment and follow-up.
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