NCT00891163

Brief Summary

The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing and thermal sensory testing evaluations), compared with a matching heated placebo patch.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
Last Updated

May 1, 2009

Status Verified

April 1, 2009

Enrollment Period

4 months

First QC Date

April 29, 2009

Last Update Submit

April 30, 2009

Conditions

Pain

Keywords

Topical anesthesiaAnalgesia

Outcome Measures

Primary Outcomes (2)

  • Sensory and pain depth measurements

    0, 30, 60, 90, 120 and 150 minutes

  • Dermal and thermal sensory testing evaluations

    0, 30, 60, 90, 120 and 150 minutes

Secondary Outcomes (2)

  • Assess the safety and tolerability of the Synera topical patch compared with a matching heated placebo patch

    Throughout the study

  • Evaluate local effects on the skin at the site of patch application for dermal adverse events (AEs)

    Throughout the study

Study Arms (2)

Synera

EXPERIMENTAL
Drug: Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)

Placebo

PLACEBO COMPARATOR
Drug: Placebo Patch

Interventions

Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)DRUG

30 minute applicable on antecubital fossa

Synera
Placebo PatchDRUG

placebo

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Had no known significant diseases
  • Normal 12-lead electrocardiogram
  • Willing to refrain from using any local topical preparations

You may not qualify if:

  • Taken over-the-counter (OTC) or prescription analgesics in any form within 24 hours
  • Known allergy or sensitivity to any component of the Synera patch, including lidocaine, sympathomimetic amines, other local anesthetics of the amide type, epinephrine, or other patch components
  • Had an active dermatological disease of any origin that may have interfered with their ability to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Medical Center, Thornton Hospital

San Diego, California, 92037-7651, United States

Location

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 29, 2009

First Posted

May 1, 2009

Study Start

December 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

May 1, 2009

Record last verified: 2009-04

Locations

US(1)