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

NCT01206595 | Completed Phase 2 Results

• 1 other identifier: SKY0402-C-203
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study was to determine the appropriate dose of SKY0402 administered as a nerve block for the management of postoperative pain following bunionectomy.

Conditions

Postoperative Pain

Keywords

Postoperative Pain; Bunionectomy; Analgesia

Outcome Measures

Primary Outcomes (1)

• Time to First Use of Supplemental Pain Medication Postoperatively for Surgical Pain

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

  Through 96 hours postdose

Secondary Outcomes (1)

• Number of Patients With Adverse Events

  Through 30 days postdose

Study Arms (2)

SKY0402

ACTIVE COMPARATOR

Low-dose (175 mg), low-mid dose( 225 mg), and mid-dose (350 mg)

Drug: SKY0402

Bupivacaine HCl

ACTIVE COMPARATOR

Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402

Drug: Bupivacaine HCl

Interventions

SKY0402 DRUG

Single dose of SKY0402 administered as a nerve block

SKY0402

Bupivacaine HCl DRUG

Single dose of 125 mg administered as a nerve block

Bupivacaine HCl

Eligibility Criteria

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

You may qualify if:

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

• Subjects were excluded from the study if they met any of the following criteria:
• Clinically significant electrocardiogram (ECG) abnormalities at Screening or on Day 1 (before dosing).
• 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 less than 60 kilograms.
• 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 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.
• Coagulation disorders or ongoing anticoagulation treatment.
• Administration of an investigational drug within 30 days or 5 half lives (of elimination), whichever was longer, prior to study drug administration.
• Suspected or known history of substance abuse and/or alcoholism.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

  Parica 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 19, 2010
• First Posted: September 22, 2010
• Study Start: March 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: December 1, 2006
• Last Updated: January 25, 2021
• Results First Posted: May 15, 2012

Record last verified: 2021-01