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

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203644
• Other study ID #: SKY0402-C-201
• Status: Completed
• Phase: Phase 2
• Start date: December 2004
• Est. completion date: December 2006

Study information

• Verified date: January 2021
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 kg/m^2

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Drug:
• SKY0402
Single dose of SKY0402 administered locally into the surgical wound.
• Bupivacaine HCl
Single dose of bupivacaine HCl (100 mg) administered locally into the surgical wound.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse Events	Safety assessments included monitoring of treatment-emergent adverse events	Through 30 days postdose