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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 May 2013 |
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Main ID: |
NCT01220024 |
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Date of registration:
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23/09/2010 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy
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Scientific title:
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A Phase II, Randomized, Single Dose, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety Profile of the CollaRx® Bupivacaine Implant (200 mg Bupivacaine Hydrochloride) in Men After Open Laparotomy Herniorrhaphy |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01220024 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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David Prior |
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Address:
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Telephone:
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Email:
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Affiliation:
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Innocoll Technologies |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Man = 18 years
- Body mass index (BMI) = 19 and = 40 kg/m2.
- Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free
technique) to be performed according to standard surgical technique under general
anesthesia.
Exclusion Criteria:
- Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
- Scheduled for bilateral inguinal herniorrhaphy.
- Undergone a prior herniorrhaphy on the side scheduled for repair.
- Undergone major surgery within 3 mos of the scheduled herniorrhaphy.
- Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
- Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or
strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide
antibiotics and grapefruit juice).
- Used long acting analgesics within 24 hours of surgery. Short acting analgesics such
as acetaminophen may be used on the day of surgery but are subject to preoperative
restrictions for oral intake.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Herniorrhaphy
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Inguinal Hernia
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Postoperative Pain
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Intervention(s)
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Drug: Bupivacaine Collagen Sponge
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Drug: Placebo collagen Sponge
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Primary Outcome(s)
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Sum of pain intensity (SPI) after aggravated movement (cough)
[Time Frame: through 72 hours after surgery]
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Secondary Outcome(s)
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SPI after aggravated movement (cough)
[Time Frame: through 48 hours after surgery]
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SPI and individual VAS PI score at rest
[Time Frame: through 72 hours after surgery]
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Total use of opioid analgesia
[Time Frame: through 72 hours after surgery]
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Secondary ID(s)
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INN-CB-010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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