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

NCT01206595 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-01-25

Study results available
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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

Interventions

DRUG

SKY0402

Single dose of SKY0402 administered as a nerve block

DRUG

Bupivacaine HCl

Single dose of 125 mg administered as a nerve block

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Kay Warnott, RN, ACNP · Parica Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2006-03-31
Completion
2006-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01206595 on ClinicalTrials.gov