CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 52 enrolled
Drug / intervention
INL-001 (bupivacaine HCl collagen implant) +1 morecombination
Likely dose
INL-001 (bupivacaine HCl collagen implant) 100 mgfrom 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.

Search/NCT03234374
NCT03234374Phase 1Completed
CompareCT.gov

A Randomized, Single Blind Study to Investigate the PK, Relative Bioavailability and Safety of INL-001 Bupivacaine HCl Collagen-Matrix Implant 300 mg Compared to Marcaine™ 0.25% (Bupivacaine HCl) 175 mg Infiltration After Open Hernioplasty

Innocoll·interventional·Posted Jul 31, 2017·Updated Jul 30, 2021

In Brief

A Phase 1 clinical trial evaluating INL-001 (bupivacaine HCl collagen implant) and Marcaine 0.25% infiltration for Hernioplasty. Completed, enrolled 52 participants across 5 sites.

Detailed Summary

This is a multicenter randomized, single-blind, controlled study. The primary objectives of this study are to obtain the pharmacokinetic profile and the relative bioavailability of the INL-001 matrix during and after open hernioplasty compared to Marcaine™ 0.25% infiltration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHernioplasty
CountriesUnited States
CollaboratorsMedpace, Inc.

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 31, 2017
Enrollment StartJun 2, 2017
Primary CompletionAug 15, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.9 years ago

Interventions

INL-001 (bupivacaine HCl collagen implant)combination

3 x 100 mg INL-001 bupivacaine HCl collagen-matrix implants (total bupivacaine HCl dose 300 mg)

Marcaine 0.25% infiltrationdrug

Marcaine 0.25% (bupivacaine HCl) 175 mg infiltration