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Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy

NCT00624910 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-07-23

Study results available
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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.

Conditions

  • Postoperative Pain

Interventions

DRUG

Bupivacaine Collagen Sponge (CollaRx®)

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.

DRUG

placebo

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.

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Innocoll

    lead INDUSTRY

Principal Investigators

  • David Prior · Innocoll

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-27
Primary Completion
2008-09-05
Completion
2008-09-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00624910 on ClinicalTrials.gov