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

NCT03313336 | Completed Phase 1

• 1 other identifier: D069GC00001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Keywords

Dermal anesthesia.; Venipuncture and intravenous cannulation.; Skin blanching or erythema.; Phase I.; Therapeutic equivalence.; Eutectic Mixture of Local anaesthetics (EMLA)

Outcome Measures

Primary Outcomes (1)

• Comparison of anesthetic efficacy of EMLA Test Patch with the marketed EMLA patch (EMLA current Reference Patch) by pain reduction assessment.

  To compare the anesthetic efficacy in pain reduction after an intravenous needle insertion whether or not actual IV insertion was achieved will be evaluated by visual analogue scale (VAS). The degree of pain experienced will be assessed on a 100 mm horizontal, non-graded paper-based VAS, with the endpoints representing "no pain" (0 mm), to "the worst possible pain" (100 mm). The VAS scores will be listed by subject, treatment sequence (TP/TR and TR/TP, where T=test, R=reference and P=Placebo), treatment (T, R and P) and hand (left, right).

  At test procedure 1 and at test procedure 2 (which is after 4 days of washout period following test procedure 1).

Secondary Outcomes (1)

• Number of participants with Adverse events (AEs), skin sensation and reactions as variables of safety and tolerability.

  From randomization until test procedure 2 or last study visit, whichever is later.

Study Arms (3)

Cohort 1

ACTIVE COMPARATOR

EMLA Test Patch.

Drug: EMLA test patch

Cohort 2

ACTIVE COMPARATOR

EMLA Reference Patch.

Drug: EMLA current reference patch

Cohort 3

PLACEBO COMPARATOR

Placebo patch.

Drug: Placebo Patch

Interventions

EMLA test patch DRUG

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.

Cohort 1

EMLA current reference patch DRUG

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.

Cohort 2

Placebo Patch DRUG

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.

Cohort 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Healthy male and female subjects aged 18 to 60 years.
• Have healthy skin over hands, with no inflammation or open wounds.
• Able to understand, read and speak the German language.
• Easy accessible veins on the dorsum of both hands.

You may not qualify if:

• Current significant active skin disease such as widespread eczema or active atopic dermatitis.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI, to local anesthetics of the amide type or to any of the components of the EMLA emulsion (e.g., castor oil polyoxyl hydrogenated).
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI to chlorohexidine (preservative in the placebo patch emulsion).
• Subjects who previously entered this study.
• Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.
• Judgement by the PI that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
• Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Pain; Erythema

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Study Officials

• Dr. med.Rainard Fuhr

  PAREXEL Early Phase Clinical Unit Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will be a double-blind, randomized, 2-period, placebo-controlled, crossover study in healthy male and female subjects, performed at a single study center. Prior to inclusion, informed consent will be obtained. A brief medical history, including limited demographic data (gender, age and ethnicity) will be recorded, and eligibility for inclusion to the study will be established through a physical inspection of hands. Subjects will be shown how to complete the visual analogue scale (VAS). At each specific study visit, each subject will undergo a left-right comparison of two patch preparations, followed by a repeated test with an alternate combination of preparations. Thus, the study will comprise: Visit 1: EMLA Test Patch plus Placebo Patch OR EMLA Test Patch plus EMLA current Reference Patch. Visit 2: EMLA Test Patch plus EMLA current Reference Patch OR EMLA Test Patch plus Placebo Patch.

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: October 18, 2017
• Study Start: October 30, 2017
• Primary Completion: November 9, 2017
• Study Completion: November 9, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)