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A Study to Assess Therapeutic Equivalence Between Test EMLA Patch With Marketed EMLA Patch in Healthy Subjects.

NCT03313336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-11-14

No results posted yet for this study

Summary

A double-blind, randomized, 2-period, placebo-controlled, single-center, crossover study, efficacy study demonstrating the therapeutic equivalence of the test cellulose disc (matrix) in EMLA patch and the current commercial cellulose disc (matrix) in EMLA patch in healthy subjects.

Conditions

Interventions

DRUG

EMLA test patch

EMLA® Test Patch containing the active ingredients lidocaine base 25 mg/g and prilocaine base 25 mg/g in an oil-in-water emulsion saturating the absorbent cellulose disc. The source of cellulose for the cellulose disc will be provided from a new supplier in this test patch.

DRUG

EMLA current reference patch

EMLA current Reference Patch, containing the active ingredients lidocaine base 25 mg/g and prilocaine base 25 mg/g in an oil-in-water emulsion saturating the absorbent cellulose disc.

DRUG

Placebo Patch

Placebo Patch, based on the EMLA Test Patch (incorporating the absorbent cellulose disc with cellulose from the current supplier), where the absorbent disc will be saturated with a placebo oil-in-water emulsion, where the eutectic mixture of lidocaine and prilocaine is replaced with fractionated coconut oil and chlorhexidine digluconate 20%, with identical appearance to the active EMLA patches.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Dr. med.Rainard Fuhr · PAREXEL Early Phase Clinical Unit Berlin

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-30
Primary Completion
2017-11-09
Completion
2017-11-09

Countries

  • Germany

Study Locations

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Diseases
Companies

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 NCT03313336 on ClinicalTrials.gov