Study of Postoperative Analgesia in Bunionectomy

• Sponsor: Pacira Pharmaceuticals, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00890682
• Collaborator: (none)
• Enrollment: 193
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 27.5

Study Details

Study Description

Brief Summary

After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.

Condition or Disease	Intervention/Treatment	Phase
Bunion; Hallux Valgus	Drug: SKY0402; Drug: Placebo	Phase 3

Detailed Description

Following drug study administration, safety and efficacy assessments were conducted

Study Design

• Study Type: Interventional
• Actual Enrollment: 193 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing First Metatarsal Osteotomy (Bunionectomy)
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sky0402 Injection of Study Drug	Drug: SKY0402; Local infiltration of 8cc SKY0402; Other Names: EXPAREL
Placebo Comparator: Placebo Injection of study drug	Drug: Placebo; Local infiltration of 8cc Placebo; Other Names: saline 0.9%

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores [0-24 hours]

   The AUC of the NRS-R pain intensity scores from time 0 through 24 hours The subject was to rest for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?"

Secondary Outcome Measures

1. Adverse Event Profile [30 days]

   Participants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 18 years at the Screening visit

• Scheduled to undergo primary unilateral first metatarsal osteotomy without hammertoe

• Female subjects must be surgically sterile or at least two years menopausal, or using an acceptable method of birth control. If of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours before surgery

• Clinical laboratory values less than or equal to twice the upper limit of normal or, if abnormal, deemed not clinically significant per the Investigator

• Ability to provide informed consent, adhere to the study visit schedule and complete all study assessments

Exclusion Criteria:

• Currently pregnant, nursing, or planning to become pregnant during the study or within one month after study drug administration

• Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week

• Use of any non-steroidal anti-inflammatory drug (NSAID) including selective COX-2 inhibitor within three days of surgery

• Use of acetaminophen within 24 hours of surgery

• Use of selective serotonin reuptake inhibitors (SSRIs), gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) within three days of surgery

• Current use of systemic glucocorticosteroids or use of systemic glucocorticoids within one month of enrollment into this study

• Peripheral neuropathy including diabetic neuropathy, chemotherapy-induced neuropathy, HIV neuropathy

• History of hepatitis

• History of, suspected, or known addiction to or abuse of drugs or alcohol within the past two years

• Failure to pass urine drug screen

• Current evidence of alcohol abuse (greater than 4 units of alcohol per day: 1 unit = ½ pint of beer, 1 glass of wine or 1 oz. of spirits)

• Evidence of peripheral ischemic disease

• Type I or Type II diabetes

• Current acute or chronic medical or major psychiatric disease that, in the opinion of the Investigator, would interfere with the evaluation of study drug efficacy or safety

• Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix

• Administration of an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study

• Previous participation in a SKY0402 study

• Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures

• Current painful physical conditions or concurrent surgery other than bunionectomy that may require analgesic treatment (such as NSAID or opioid) in the postoperative period for pain that is not strictly related to the bunionectomy procedure and may confound the postoperative assessments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Premier Research Group	Austin	Texas	United States	78705

Sponsors and Collaborators

• Pacira Pharmaceuticals, Inc

Investigators

• Principal Investigator: Stephen Daniels, DO, Premier Research Group Clinical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pacira Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT00890682
• Other Study ID Numbers: SKY0402C317
• First Posted: Apr 30, 2009
• Last Update Posted: Aug 5, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Pacira Pharmaceuticals, Inc: Bunion; Bunionectomy; Osteotomy
• Additional relevant MeSH terms: Hallux Valgus; Bunion

Study Results

Participant Flow

Arm/Group Title	SKY0402	Placebo
Arm/Group Description	Injection of 8cc SKY0402 (single dose)	Injection of 8cc Placebo (single dose)
Period Title: Overall Study
STARTED	97	96
COMPLETED	93	94
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Sky0402	Placebo	Total
Arm/Group Description	Injection of Study Drug	Study Drug Injection	Total of all reporting groups
Overall Participants	97	96	193
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	97 100%	92 95.8%	189 97.9%
>=65 years	0 0%	4 4.2%	4 2.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.4 (12.6)	43.2 (13.3)	42.8 (13.0)
Sex: Female, Male (Count of Participants)
Female	75 77.3%	84 87.5%	159 82.4%
Male	22 22.7%	12 12.5%	34 17.6%
Region of Enrollment (participants) [Number]
United States	97 100%	96 100%	193 100%

Outcome Measures

1. Primary Outcome

Title	Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
Description	The AUC of the NRS-R pain intensity scores from time 0 through 24 hours The subject was to rest for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?"
Time Frame	0-24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SKY0402	Placebo
Arm/Group Description	Single injection of study drug	Single injection of study drug
Measure Participants	97	96
Geometric Mean (Standard Error) [Units on a scale*hours]	124 (4.5)	146 (4.6)

2. Secondary Outcome

Title	Adverse Event Profile
Description	Participants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Sky0402		Placebo
Arm/Group Description	Injection of Study Drug		Study Drug Injection
All Cause Mortality
	Sky0402		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Sky0402		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		1/96 (1%)
Vascular disorders
Deep Vein Thrombosis	0/97 (0%)	0	1/96 (1%)	1
Other (Not Including Serious) Adverse Events
	Sky0402		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	56/97 (57.7%)		63/96 (65.6%)
Gastrointestinal disorders
Nausea	39/97 (40.2%)		36/96 (37.5%)
Vomiting	27/97 (27.8%)		17/96 (17.7%)
Nervous system disorders
Dizziness	11/97 (11.3%)		25/96 (26%)
Headache	5/97 (5.2%)		8/96 (8.3%)
Somnolence	5/97 (5.2%)		1/96 (1%)	1
Skin and subcutaneous tissue disorders
Pruritis	5/97 (5.2%)		6/96 (6.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.