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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: | NCT00661466 |
The purpose of this study is to determine whether the CollaRx Bupivacaine Implant (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after gastrointestinal (GI) surgery.
Condition | Intervention | Phase |
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Pain, Postoperative |
Drug: Bupivacaine Collagen Sponge Drug: Placebo |
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 Patients After Gastrointestinal Surgery |
Estimated Enrollment: | 58 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
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Drug: Bupivacaine Collagen Sponge
The bupivacaine sponge contains 70 mg Type I bovine collagen and 50 mg bupivacaine hydrochloride
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2: Placebo Comparator
Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.
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Drug: Placebo
The placebo sponge contains 70mg Type 1 bovine collagen
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Gastrointestinal (GI) surgery encompasses a range of surgical procedures that involve abdominal incision.
Gastrointestinal surgery may be performed to treat an abdominal aortic aneurysm, ulcerative colitis, Crohn's disease, gallbladder disease, bile duct disease and morbid obesity. Although less invasive laparoscopic procedures are performed when warranted, open abdominal surgery is required for certain indications and for more complicated or advanced cases.
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 for 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 the CollaRx Bupivacaine implant or a plain collagen sponge.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Requires any additional surgical procedures either related or unrelated to the GI surgery during the same hospitalization.
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, New York | |
Albany Medical Center Hospital | Recruiting |
Albany, New York, United States, 12208 | |
Principal Investigator: Scott Groudine, MD |
Study Director: | David Prior | Innocoll Technologies |
Responsible Party: | Innocoll Holdings Inc. ( David Prior ) |
Study ID Numbers: | INN-CB-004 |
Study First Received: | April 15, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00661466 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Gastrointestinal surgery Post operative pain |
Signs and Symptoms Postoperative Complications Central Nervous System Depressants Anesthetics Bupivacaine |
Pain Peripheral Nervous System Agents Anesthetics, Local Pain, Postoperative |
Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pain Anesthetics, Local Pharmacologic Actions Signs and Symptoms Pathologic Processes |
Postoperative Complications Sensory System Agents Therapeutic Uses Bupivacaine Peripheral Nervous System Agents Central Nervous System Agents Pain, Postoperative |