CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) +1 moredrug
Likely dose
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) 70mgfrom 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/NCT00749749
NCT00749749Phase 2Completed
CompareCT.gov

A Phase II, Randomized, Single-dose, Unblinded Study to Compare the Efficacy and Safety of the CollaRx Bupivacaine Implant With the ON-Q PainBuster Post-op Pain Relief System in Women Following Abdominal Hysterectomy

Innocoll·interventional·Posted Sep 9, 2008·Updated Nov 4, 2020

In Brief

A Phase 2 clinical trial evaluating Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) and ON-Q PainBuster Post-op Pain relief System for Pain, Postoperative. Completed, enrolled 27 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether the CollaRx Bupivacaine Implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster Post-op Pain Relief System.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative
CountriesUnited States
CollaboratorsPremier Research

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2008
Enrollment StartSep 10, 2008
Primary CompletionDec 22, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.8 years ago

Interventions

Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant)drug

The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride

ON-Q PainBuster Post-op Pain relief Systemdrug

5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])