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

NCT01203644 | Completed Phase 2 Results

• 1 other identifier: SKY0402-C-201
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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, 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.

Conditions

Inguinal Hernia

Keywords

Postoperative pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• Time to First Use of Supplemental Pain Medication

  The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical wound pain

  Through 96 hours postdose

Secondary Outcomes (1)

• Adverse Events

  Through 30 days postdose

Study Arms (2)

Bupivacaine HCl

ACTIVE COMPARATOR

(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

SKY0402

ACTIVE COMPARATOR

Low dose, low-mid dose, mid-dose, and high dose

Drug: Bupivacaine HCl

Interventions

SKY0402 DRUG

Single dose of SKY0402 administered locally into the surgical wound.

Bupivacaine HCl

Bupivacaine HCl DRUG

Single dose of bupivacaine HCl (100 mg) administered locally into the surgical wound.

SKY0402

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Related Publications (1)

• Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.

  PMID: 22900785 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Executive Medical Director
• Organization: Pacira Pharmaceuticals, Inc.

ErolOnel@pacira.com

203-837-6500

Study Officials

• Kay Warnott, RN, ACNP

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: December 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: December 1, 2006
• Last Updated: January 25, 2021
• Results First Posted: May 14, 2012

Record last verified: 2021-01