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Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy

NCT01220024 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-03-10

Study results available
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Summary

This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Conditions

  • Herniorrhaphy
  • Postoperative Pain
  • Inguinal Hernia

Interventions

DRUG

Bupivacaine Collagen Sponge

Drug: Bupivacaine Collagen Sponge

DRUG

Placebo collagen Sponge

Drug: Placebo Collagen Sponge

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
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-02
Primary Completion
2011-05-18
Completion
2011-05-18

Countries

  • United States

Study Locations

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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 NCT01220024 on ClinicalTrials.gov