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Sponsors and Collaborators: |
Innocoll Technologies Premier Research Group plc |
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Information provided by: | Innocoll Technologies |
ClinicalTrials.gov Identifier: | NCT00626886 |
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 herniorrhaphy.
Condition | Intervention | Phase |
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Herniorrhaphy Postoperative Pain Inguinal Hernia |
Drug: Bupivacaine Collagen Sponge Drug: placebo collagen sponge |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Single Dose, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Pharmacokinetic Profile of the CollaRx® Bupivacaine Implant in Men After Open Mesh Herniorrhaphy |
Estimated Enrollment: | 52 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
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Drug: Bupivacaine Collagen Sponge
The bupivacaine collagen sponge contains 70mg Type 1 collagen and 50 mg bupivcaine hydrochloride. A total of 2 sponges will be implanted during surgery; the first sponge will be implanted into the abdominal wall repair, mesh will be placed on top of this, the second sponge will be implanted into the skin incision and the wound will be closed.
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2: Placebo Comparator
Placebo collagen sponge implanted during surgery
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Drug: placebo collagen sponge
The placebo collagen sponge contains 70mg Type 1 collagen. A total of 2 sponges will be implanted during surgery; the first sponge will be implanted into the abdominal wall repair, mesh will be placed on top of this, the second sponge will be implanted into the skin incision and the wound will be closed.
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Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.
Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.
This study will compare the amount of narcotic pain medication required after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Clare OConnell | 512-320-1612 ext 1523 | surgicalpainstudies@premier-research.com |
Contact: Kelly Webb | 512-320-1612 ext 1520 | surgicalpainstudies@premier-research.com |
United States, California | |
Advanced Clinical Research Institute | Recruiting |
Anaheim, California, United States, 92801 | |
Principal Investigator: Dennis S Riff, MD, FACG |
Study Director: | David Prior | Innocoll Technologies |
Responsible Party: | Innocoll Technologies ( David Prior ) |
Study ID Numbers: | INN-CB-003 |
Study First Received: | February 20, 2008 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00626886 |
Health Authority: | United States: Food and Drug Administration |
Herniorrhaphy Inguinal Hernia Repair Postoperative pain |
Pathological Conditions, Anatomical Signs and Symptoms Postoperative Complications Hernia Hernia, Abdominal |
Bupivacaine Pain Hernia, Inguinal Pain, Postoperative |
Pathologic Processes Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants |
Anesthetics Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |