At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 64 enrolled
Drug / intervention
2 100mg Xaracoll implants +2 moredrug
Likely dose
2 100mg Xaracoll implantsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Blinded, Inpatient Study to Investigate the PK, Relative Bioavailability and Safety of 2 Doses of XaraColl (200 and 300 mg Bupivacaine HCl) Compared to Bupivacaine HCl Infiltration (150 mg) After Open Laparotomy Hernioplasty
In Brief
A Phase 2 clinical trial evaluating 2 100mg Xaracoll implants, 3 100mg Xaracoll implants, and 1 other intervention for Hernioplasty. Completed, enrolled 64 participants across 5 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHernioplasty
CountriesUnited States
CollaboratorsPremier Research
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartOct 2014
Primary CompletionFeb 2015
Study CompletionMar 2015
TodayJul 2026
First PostedSep 5, 2014
Enrollment StartOct 20, 2014
Primary CompletionFeb 23, 2015
Study CompletionMar 23, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.8 years ago
Interventions
2 100mg Xaracoll implantsdrug
3 100mg Xaracoll implantsdrug
150mg Bupivacaine HCl injectiondrug