Status:
COMPLETED
Evaluation of the Safety, Efficacy, and Pharmacokinetics of SKY0402 in Subjects Undergoing Inguinal Hernia Repair
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Inguinal Hernia
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study was to determine the appropriate dose of SKY0402 for the management of postoperative pain following inguinal hernia repair. This study evaluated the safety, efficac...
Detailed Description
SKY0402 was administered in a dose escalating/de-escalating fashion, with a low starting dose in Cohort 1 that was to be increased or decreased in subsequent cohorts based on safety and analgesic effe...
Eligibility Criteria
Inclusion
- Males ≥18 years of age at the Screening visit.
- Scheduled to undergo unilateral inguinal hernia repair under general anesthesia, using an open, tension free procedure (e.g., Lichtenstein technique with or without mesh).
- American Society of Anesthesiology (ASA) Physical Class 1 or 2.
- Able and willing to comply with all study visits and procedures.
- Capable of speaking and understanding the local language sufficiently to provide responses to pain assessment scales.
- Willing and capable of providing written informed consent.
Exclusion
- Clinically significant electrocardiogram abnormalities at Screening or on Day 1 (pre administration).
- Albumin and/or alpha 1 acid glycoprotein (AAG) below normal levels.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, might have increased the risk of surgery or complicated the subject's postoperative course.
- Opioid medication usage during the 7 day period preceding the administration of study drug.
- Current medical conditions that could have required treatment with analgesic medications in the postoperative period for pain that was not surgically related (e.g., rheumatoid arthritis).
- Body mass index \>30 kg/m\^2
- Body weight \<60 kg.
- History of hypersensitivity or idiosyncratic reaction to amide type local anesthetic agents.
- History of hypersensitivity, idiosyncratic reactions, and other contraindications to the pain control agents (opioid or non-opioid) anticipated to be used postoperatively. These contraindications may have included: angioedema and bronchospastic reactivity to non steroidal anti inflammatory drug, peptic ulcer (active within the last three months), hepatic or renal insufficiency.
- Coagulation disorders or ongoing anticoagulation treatment.
- Administration of an investigational drug within 30 days or five half lives (of elimination), whichever was longer, prior to study drug administration.
- Suspected or known history of substance abuse and/or alcoholism.
- Clinically significant complications during the hernia repair surgery (e.g., excessive bleeding), which might have rendered the subject medically unstable or might have complicated the subject's postoperative course.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01203644
Start Date
December 1 2004
End Date
December 1 2006
Last Update
January 25 2021
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