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| Sponsor: | Innocoll Technologies |
|---|---|
| Collaborator: |
Premier Research Group plc |
| Information provided by: | Innocoll Technologies |
| ClinicalTrials.gov Identifier: | NCT00626886 |
Purpose
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 |
|---|---|---|
|
Postoperative Pain Inguinal Hernia |
Drug: Bupivacaine Collagen Sponge Drug: placebo collagen sponge |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 53 |
| Study Start Date: | January 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
|
Drug: Bupivacaine Collagen Sponge
collagen; Bupivacaine hydrocholoride
Other Name: CollaRx Bupivacaine Implant
|
|
Placebo Comparator: 2
Placebo collagen sponge implanted during surgery
|
Drug: placebo collagen sponge
collagen
Other Name: Placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Advanced Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| Study Director: | David Prior | Innocoll Technologies |
More Information
| Responsible Party: | David Prior, Innocoll Technologies |
| ClinicalTrials.gov Identifier: | NCT00626886 History of Changes |
| Other Study ID Numbers: | INN-CB-003 |
| Study First Received: | February 20, 2008 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Herniorrhaphy Inguinal Hernia Repair Postoperative pain |
|
Hernia Hernia, Inguinal Pain, Postoperative Pathological Conditions, Anatomical Hernia, Abdominal Postoperative Complications Pathologic Processes Pain Signs and Symptoms Bupivacaine |
Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |