Trial Outcomes & Findings for Safety, Efficacy, and Pharmacokinetics of SKY0402 Administered as a Nerve Block in Subjects Undergoing Bunionectomy (NCT NCT01206595)

NCT ID: NCT01206595

Last Updated: 2021-01-25

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 58 participants
• Primary outcome timeframe: Through 96 hours postdose
• Results posted on: 2021-01-25

Participant Flow

Participant milestones

Measure	SKY0402 Low-dose, low-mid dose, and mid-dose	Bupivacaine HCl Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
Overall Study STARTED	38	20
Overall Study COMPLETED	38	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	SKY0402 n=38 Participants Low-dose, low-mid dose, and mid-dose	Bupivacaine HCl n=20 Participants Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	15 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Age, Continuous	54.3 years STANDARD_DEVIATION 14.04 • n=5 Participants	55.7 years STANDARD_DEVIATION 14.22 • n=7 Participants	54.8 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	18 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Australia	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Belgium	29 participants n=5 Participants	12 participants n=7 Participants	41 participants n=5 Participants
Region of Enrollment United Kingdom	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Netherlands	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Through 96 hours postdose

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

Outcome measures

Measure	Bupivacaine HCl n=20 Participants A single dose of bupivacaine HCl 125 mg was administered intraoperatively by local infiltration.	SKY0402 Low Dose (175 mg) n=12 Participants A single dose of SKY0402 Low Dose (175 mg) was administered intraoperatively by local infiltration.	SKY0402 Low-Mid Dose (225 mg) n=12 Participants A single dose of SKY0402 low-mid dose (225 mg) was administered intraoperatively by local infiltration.	SKY0402 Mid Dose (350 mg) n=14 Participants A single dose of SKY0402 mid dose (350 mg) was administered intraoperatively by local infiltration.
Time to First Use of Supplemental Pain Medication Postoperatively for Surgical Pain	9.4 hours Interval 6.1 to 11.2	1.9 hours Interval 0.3 to 9.0	1.2 hours Interval 0.6 to 5.4	2.4 hours Interval 0.3 to 8.3

SECONDARY outcome

Timeframe: Through 30 days postdose

All adverse events were to be recorded from the time of dosing through Day 8. Serious adverse events (SAEs) were to be recorded through Day 30.

Outcome measures

Outcome data not reported

Adverse Events

SKY0402

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Bupivacaine HCl

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	SKY0402 n=38 participants at risk Low-dose, low-mid dose, and mid-dose	Bupivacaine HCl n=20 participants at risk Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
Injury, poisoning and procedural complications Immobiliaztion prolonged	2.6% 1/38	0.00% 0/20

Other adverse events

Measure	SKY0402 n=38 participants at risk Low-dose, low-mid dose, and mid-dose	Bupivacaine HCl n=20 participants at risk Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
Cardiac disorders Bradycardia	5.3% 2/38	0.00% 0/20
Gastrointestinal disorders Constipation	5.3% 2/38	0.00% 0/20
Gastrointestinal disorders Nausea	23.7% 9/38	15.0% 3/20
Gastrointestinal disorders Vomiting	7.9% 3/38	0.00% 0/20
Nervous system disorders Headache	5.3% 2/38	0.00% 0/20
Vascular disorders Hypotension	0.00% 0/38	15.0% 3/20

Additional Information

Executive Medical Director

Pacira Pharmaceuticals, Inc.

Phone: 203-837-6500

Email: ErolOnel@pacira.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place