Evaluation of the Safety, Efficacy, and Pharmacokinetics of SKY0402 in Subjects Undergoing Inguinal Hernia Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01203644
First received: September 15, 2010
Last updated: April 15, 2012
Last verified: November 2011
  Purpose

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, efficacy, and pharmacokinetics of SKY0402 compared with a 100 mg dose of bupivacaine HCl for the treatment of postoperative pain in subjects undergoing inguinal hernia repair. Study drug was administered by surgical wound infiltration at the end of the hernia repair procedure.


Condition Intervention Phase
Inguinal Hernia
Drug: SKY0402
Drug: Bupivacaine HCl
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double Blind, Dose Escalating/ De Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of a Single Dose of Sustained Release Encapsulated Bupivacaine (SKY0402) in the Management of Postoperative Pain in Subjects Undergoing Inguinal Hernia Repair

Resource links provided by NLM:


Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Time to First Use of Supplemental Pain Medication [ Time Frame: Through 96 hours postdose ] [ Designated as safety issue: No ]
    The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical wound pain


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Through 30 days postdose ] [ Designated as safety issue: Yes ]
    Safety assessments included monitoring of treatment-emergent adverse events


Enrollment: 76
Study Start Date: December 2004
Study Completion Date: December 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupivacaine HCl
(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
Drug: SKY0402
Single dose of SKY0402 administered locally into the surgical wound.
Active Comparator: SKY0402
Low dose, low-mid dose, mid-dose, and high dose
Drug: Bupivacaine HCl
Single dose of bupivacaine HCl (100 mg) administered locally into the surgical wound.

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 effects. The decision to proceed to the next cohort (i.e., increase or decrease the dose) was made by a Cohort Data Review Committee following a review of the data from the previous cohort. Subjects were randomized to receive either SKY0402 or bupivacaine HCl at a ratio of 1:1 in Cohort 1 and at a ratio of 3:1 in subsequent cohorts. The dose of bupivacaine HCl (100 mg) remained constant for all cohorts.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males ≥18 years of age at the Screening visit.
  2. Scheduled to undergo unilateral inguinal hernia repair under general anesthesia, using an open, tension free procedure (e.g., Lichtenstein technique with or without mesh).
  3. American Society of Anesthesiology (ASA) Physical Class 1 or 2.
  4. Able and willing to comply with all study visits and procedures.
  5. Capable of speaking and understanding the local language sufficiently to provide responses to pain assessment scales.
  6. Willing and capable of providing written informed consent.

Exclusion Criteria:

  1. Clinically significant electrocardiogram abnormalities at Screening or on Day 1 (pre administration).
  2. Albumin and/or alpha 1 acid glycoprotein (AAG) below normal levels.
  3. 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.
  4. Opioid medication usage during the 7 day period preceding the administration of study drug.
  5. 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).
  6. Body mass index >30 mg/kg2.
  7. Body weight <60 kg.
  8. History of hypersensitivity or idiosyncratic reaction to amide type local anesthetic agents.
  9. 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.
  10. Coagulation disorders or ongoing anticoagulation treatment.
  11. Administration of an investigational drug within 30 days or five half lives (of elimination), whichever was longer, prior to study drug administration.
  12. Suspected or known history of substance abuse and/or alcoholism.
  13. 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01203644

Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
Study Director: Kay Warnott, RN, ACNP Pacira Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01203644     History of Changes
Other Study ID Numbers: SKY0402-C-201
Study First Received: September 15, 2010
Results First Received: November 23, 2011
Last Updated: April 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
Postoperative pain
Analgesia

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 20, 2014