CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Bupivacaine Collagen Sponge (CollaRx®) +1 moredrug
Likely dose
Bupivacaine Collagen Sponge (CollaRx®) 70 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/NCT00624910
NCT00624910Phase 2Completed
CompareCT.gov

A Phase II, Single-dose, Blinded, Prospective Study to Investigate the Efficacy and Safety of the CollaRx® Bupivacaine Implant in Women Following Abdominal Hysterectomy or Other Nonlaparoscopic Benign Gynecological Procedure

Innocoll·interventional·Posted Feb 28, 2008·Updated Jul 23, 2021

In Brief

A Phase 2 clinical trial evaluating Bupivacaine Collagen Sponge (CollaRx®) and placebo for Postoperative Pain. Completed, enrolled 54 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 24 hours after abdominal hysterectomy surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
CollaboratorsPremier Research

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 28, 2008
Enrollment StartDec 27, 2007
Primary CompletionSep 5, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.3 years ago

Interventions

Bupivacaine Collagen Sponge (CollaRx®)drug

The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.

placebodrug

The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.