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

This study has been completed.
Sponsor:
Information provided by:
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00806806
First received: December 9, 2008
Last updated: August 31, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Postoperative Pain Management
Drug: SKY0402
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
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

Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • time to onset of action [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time to onset [ Time Frame: bewteen 15 and 30 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 128
Study Start Date: October 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Local administration of Placebo followed by noxious stimuli
Experimental: SKY0402 Drug: SKY0402
Local administration of SKY0402 followed by noxious stimulus

Detailed Description:

Subjects will be given either SKY0402 or placebo in response to a noxious stimulus, and the time to onset will be recorded.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806806

Locations
United States, Ohio
The Ohio State University College of Medicine, Dept of Pharmacology
Columbus, Ohio, United States, 43210-1239
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
Study Director: Marius Ardeleanu, MD Pacira Pharmaceuticals, Inc
  More Information

No publications provided by Pacira Pharmaceuticals, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marius Ardeleanu, MD, Director, Clinical Research, Pacira Pharmaceucticals, Inc.
ClinicalTrials.gov Identifier: NCT00806806     History of Changes
Other Study ID Numbers: SKY0402C109
Study First Received: December 9, 2008
Last Updated: August 31, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
pain management
postoperative

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014