CLINICAL TRIALS PROFILE FOR XARACOLL
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All Clinical Trials for xaracoll
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02232178 ↗ | 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. |
| NCT02232178 ↗ | 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. |
| NCT02523599 ↗ | 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. |
| NCT02525133 ↗ | Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty | Completed | Innocoll | Phase 3 | 2015-09-05 | 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. |
| NCT03262688 ↗ | Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair | Recruiting | Cmed | Phase 3 | 2017-06-16 | A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, and 2 to <6 years of age who are scheduled for elective open inguinal hernia repair. Enrollment in this study will start with the oldest age group (12 to <17 years) and will continue in a stepwise fashion until appropriate doses are established for all 3 pediatric age groups (12 to <17 years, 6 to <12 years, 2 to <6 years). |
| NCT03262688 ↗ | Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair | Recruiting | Premier Research Group plc | Phase 3 | 2017-06-16 | A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, and 2 to <6 years of age who are scheduled for elective open inguinal hernia repair. Enrollment in this study will start with the oldest age group (12 to <17 years) and will continue in a stepwise fashion until appropriate doses are established for all 3 pediatric age groups (12 to <17 years, 6 to <12 years, 2 to <6 years). |
| NCT03262688 ↗ | Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair | Recruiting | Innocoll | Phase 3 | 2017-06-16 | A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, and 2 to <6 years of age who are scheduled for elective open inguinal hernia repair. Enrollment in this study will start with the oldest age group (12 to <17 years) and will continue in a stepwise fashion until appropriate doses are established for all 3 pediatric age groups (12 to <17 years, 6 to <12 years, 2 to <6 years). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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