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Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers (TTO)

Primary Purpose

Postoperative Pain Management

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SKY0402
Placebo
Sponsored by
Pacira Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain Management focused on measuring pain management, postoperative

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects eligible for study entry will meet the following criteria:

  • Male or female, ages at least 18 years and not over 55 years.
  • Body mass index (BMI) within the range 20.0 to 30.0 kg/m2, inclusive.
  • Applies to females only: Female subjects of childbearing potential with a nonsterilized male sexual partner must agree to use a hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device beginning > 30 days prior to the first dosing and continuing until > 7 days after the end of the study. Female subjects who are postmenopausal must have been postmenopausal for > 1 year if they wish not to use contraceptives.
  • Good general health, evidenced by a lack of significantly abnormal findings on medical history and screening assessments.
  • Pain intensity score of > 30 mm on a VAS after incision and application of an 18% acetic acid solution to nontreated skin (i.e., not infiltrated with any test or control article) at Screening.
  • Able and willing to comply with all study visits and procedures, including returning as scheduled for the second treatment visit.
  • Able to speak, read, and understand the language of the ICF, study questionnaires, and other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to pain scales and other required study assessments.
  • Willing and capable of providing written informed consent.

Exclusion Criteria:

A subject will not be eligible for the study if he or she meets any of the following criteria:

  • A history of hypersensitivity to amide type local anesthetics.
  • Pregnancy, nursing, or planning to become pregnant during the course of the study.
  • Any current conditions that might interfere with pain assessments, including current pain.
  • Conditions of the skin or neurological abnormalities that might alter pain sensitivity. These include excessive scarring, burns, skin grafts, and trauma. Tattoos are permitted.
  • A history of keloid formation.
  • A coagulopathy or use of medications that might enhance bleeding.
  • Use of any of the following medication within the times specified before study drug administration:

    • Long-acting opioid mediations within 3 days.
    • Any opioid medication within 24 hours.
    • Any analgesic medication within 12 hours.
  • Consumption of alcohol within 24 hours before either treatment visit.
  • Any condition that, in the opinion of the Investigator, renders a subject unsuitable for participation in the study. NOTE: The specific reason(s) for exclusion will be documented in the Screening Log.
  • Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

Minor deviations in eligibility criteria are permitted if approved by the Pacira Medical Monitor in agreement with the Investigator prior to dosing.

Sites / Locations

  • The Ohio State University College of Medicine, Dept of Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

SKY0402

Arm Description

Outcomes

Primary Outcome Measures

time to onset of action

Secondary Outcome Measures

time to onset

Full Information

First Posted
December 9, 2008
Last Updated
August 31, 2010
Sponsor
Pacira Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00806806
Brief Title
Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers
Acronym
TTO
Official Title
A Phase 1 Randomized, Single-blind, Sequential Cohort, Crossover Study to Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pacira Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Given as a single perioperative injection, SKY0402 could provide adequate, continuous, and extended pain relief that could greatly simplify postoperative pain management, reduce the need for repeated administration, and minimize episodes of breakthrough pain.
Detailed Description
Subjects will be given either SKY0402 or placebo in response to a noxious stimulus, and the time to onset will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Management
Keywords
pain management, postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
SKY0402
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SKY0402
Intervention Description
Local administration of SKY0402 followed by noxious stimulus
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Local administration of Placebo followed by noxious stimuli
Primary Outcome Measure Information:
Title
time to onset of action
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
time to onset
Time Frame
bewteen 15 and 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects eligible for study entry will meet the following criteria: Male or female, ages at least 18 years and not over 55 years. Body mass index (BMI) within the range 20.0 to 30.0 kg/m2, inclusive. Applies to females only: Female subjects of childbearing potential with a nonsterilized male sexual partner must agree to use a hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device beginning > 30 days prior to the first dosing and continuing until > 7 days after the end of the study. Female subjects who are postmenopausal must have been postmenopausal for > 1 year if they wish not to use contraceptives. Good general health, evidenced by a lack of significantly abnormal findings on medical history and screening assessments. Pain intensity score of > 30 mm on a VAS after incision and application of an 18% acetic acid solution to nontreated skin (i.e., not infiltrated with any test or control article) at Screening. Able and willing to comply with all study visits and procedures, including returning as scheduled for the second treatment visit. Able to speak, read, and understand the language of the ICF, study questionnaires, and other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to pain scales and other required study assessments. Willing and capable of providing written informed consent. Exclusion Criteria: A subject will not be eligible for the study if he or she meets any of the following criteria: A history of hypersensitivity to amide type local anesthetics. Pregnancy, nursing, or planning to become pregnant during the course of the study. Any current conditions that might interfere with pain assessments, including current pain. Conditions of the skin or neurological abnormalities that might alter pain sensitivity. These include excessive scarring, burns, skin grafts, and trauma. Tattoos are permitted. A history of keloid formation. A coagulopathy or use of medications that might enhance bleeding. Use of any of the following medication within the times specified before study drug administration: Long-acting opioid mediations within 3 days. Any opioid medication within 24 hours. Any analgesic medication within 12 hours. Consumption of alcohol within 24 hours before either treatment visit. Any condition that, in the opinion of the Investigator, renders a subject unsuitable for participation in the study. NOTE: The specific reason(s) for exclusion will be documented in the Screening Log. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study. Minor deviations in eligibility criteria are permitted if approved by the Pacira Medical Monitor in agreement with the Investigator prior to dosing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Ardeleanu, MD
Organizational Affiliation
Pacira Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
The Ohio State University College of Medicine, Dept of Pharmacology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23458225
Citation
Apseloff G, Onel E, Patou G. Time to onset of analgesia following local infiltration of liposome bupivacaine in healthy volunteers: a randomized, single-blind, sequential cohort, crossover study. Int J Clin Pharmacol Ther. 2013 May;51(5):367-73. doi: 10.5414/CP201775.
Results Reference
derived

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Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers

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