Safety, Efficacy, and Pharmacokinetics of SKY0402 Administered as a Nerve Block in Subjects Undergoing Bunionectomy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01206595
• Date of registration: 19/09/2010
• Primary sponsor: Pacira Pharmaceuticals, Inc
• Public title: Safety, Efficacy, and Pharmacokinetics of SKY0402 Administered as a Nerve Block in Subjects Undergoing Bunionectomy
• Scientific title: A Phase 2, Multicenter, Randomized, Double Blind, Dose Escalating/ De-Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sustained Release Encapsulated Bupivacaine (SKY0402) Administered as a Nerve Block in the Management of Postoperative Pain in Subjects Undergoing Bunionectomy
• Date of first enrolment: March 2005
• Target sample size: 58
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01206595
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Contacts

• Name: Kay Warnott, RN, ACNP
• Affiliation: Parica Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

Subjects were eligible for enrollment if they met the following criteria:

1. Males and females =18 years of age at the Screening Visit. NOTE: Eligible females
were postmenopausal or surgically sterile, or, if of child bearing potential, were
not pregnant or nursing, and they agreed to not become pregnant during the study by
using acceptable means of contraception for at least 1 month before and 1 month after
dosing, including any of the following: hormonal contraceptives (oral, injectable,
implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine
device (IUD), lifestyle with a personal choice of abstinence, non-heterosexual
lifestyle, or in a strictly monogamous relationship with a partner who has had a
vasectomy.

2. Scheduled to undergo a primary unilateral first metatarsal bunionectomy repair under
general anesthesia, with or without internal fixation.

NOTE: For the purpose of this protocol, all surgical procedures involving osteotomy
of the first metatarsal (significant bone resection, excision, surgical fracture,
etc.) or fusion of the first metatarsal phalangeal joint were considered qualified
procedures, whether or not performed specifically to repair a bunion (hallus valgus
deformity). Surgical techniques accompanied by minimal bone excision (e.g.
cheilectomy) or procedures limited to soft tissue repair were not eligible for this
study.

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:

Subjects were excluded from the study if they met any of the following criteria:

1. Clinically significant electrocardiogram (ECG) abnormalities at Screening or on Day 1
(before dosing).

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 less than 60 kilograms.

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 the following: angioedema
and bronchospastic reactivity to non-steroidal anti-inflammatory drug (NSAID), peptic
ulcer (active within the last 3 months), or hepatic or renal insufficiency.

10. Coagulation disorders or ongoing anticoagulation treatment.

11. Administration of an investigational drug within 30 days or 5 half lives (of
elimination), whichever was longer, prior to study drug administration.

12. Suspected or known history of substance abuse and/or alcoholism.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Postoperative Pain

Intervention(s)

Drug: Bupivacaine HCl

Drug: SKY0402

Primary Outcome(s)

Time to First Use of Supplemental Pain Medication Postoperatively for Surgical Pain [Time Frame: Through 96 hours postdose]

Secondary Outcome(s)

Number of Patients With Adverse Events [Time Frame: Through 30 days postdose]

Secondary ID(s)

SKY0402-C-203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors