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

NCT00806806 | Completed Phase 1

• 1 other identifier: SKY0402C109
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain Management

Keywords

pain management; postoperative

Outcome Measures

Primary Outcomes (1)

• time to onset of action

  15 minutes

Secondary Outcomes (1)

• time to onset

  bewteen 15 and 30 minutes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

SKY0402

EXPERIMENTAL

Drug: SKY0402

Interventions

SKY0402 DRUG

Local administration of SKY0402 followed by noxious stimulus

SKY0402

Placebo DRUG

Local administration of Placebo followed by noxious stimuli

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

The Ohio State University College of Medicine, Dept of Pharmacology

Columbus, Ohio, 43210-1239, United States

Location

Related Publications (1)

• 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.

  PMID: 23458225 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marius Ardeleanu, MD

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 11, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: September 6, 2010

Record last verified: 2010-08

Locations

US (1)