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COMPLETEDPHASE3

Study of Postoperative Analgesia in Bunionectomy

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)

NCT00890682•Pacira Pharmaceuticals, Inc

View on ClinicalTrials.gov

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.

Detailed Description

Following drug study administration, safety and efficacy assessments were conducted

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

Locations (1)

Premier Research Group

Austin, Texas, United States

Key Dates

Start Date

April 1, 2009

Primary Completion Date

November 1, 2009

Completion Date

November 1, 2009

Last Updated

August 5, 2013

Enrollment

193

ACTUAL participants

Conditions

BunionHallux Valgus

Interventions

SKY0402

DRUG

Placebo

DRUG

Evaluation of a New Postoperative Dressing After Hallux Valgus Surgery

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Hallux Valgus

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RECRUITINGNA

A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery

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Hallux ValgusOrthopedic Disorder

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RECRUITINGNA

Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Postoperative Analgesia in Bunionectomy

Inclusion Criteria

Exclusion Criteria

Evaluation of a New Postoperative Dressing After Hallux Valgus Surgery

A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery

Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery

LSTR in Chevron Osteotomy

Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery

Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device