PainPhase 1EMLANCT03313336
A Study to Assess Therapeutic Equivalence Between Test EMLA Patch With Marketed EMLA Patch in Healthy Subjects.
A Phase 1 study testing EMLA test patch and EMLA current reference patch in people with Pain, run by AstraZeneca at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- EMLA test patch and EMLA current reference patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 30 Oct 2017to 9 Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, 2-period, Placebo-controlled, Single-center, Crossover Study to Assess the Therapeutic Equivalence of the EMLA Current Reference Patch and the EMLA Test Patch in Healthy Subjects.
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.
Read the detailed description
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 VAS. Visual analogue scale (VAS) as a research tool is frequently used for the assessment of pain severity and relief. VAS is easy to use and can be applied in a variety of settings; results are reproducible. VAS data are sensitive to treatment effects and can be analyzed using parametric statistical techniques. 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. There will be a washout period of at minimum of 4 calendar days between treatment periods (visits). No follow-up visit is needed. Any adverse event (AE) that is ongoing at the last visit will be followed up as appropriate.
- Conditions
- Pain
- Being tested
- EMLA test patch, EMLA current reference patch, Placebo Patch
- Keywords
- Dermal anesthesia., Venipuncture and intravenous cannulation., Skin blanching or erythema., Phase I., Therapeutic equivalence., Eutectic Mixture of Local anaesthetics (EMLA)
- Medical subject headings
- Pain, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLA test patchDrug
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.
EMLA current reference patchDrug
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.
Placebo PatchDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | EMLA Test Patch. Receives: Drug: EMLA test patch |
| Cohort 2 | Active comparator | EMLA Reference Patch. Receives: Drug: EMLA current reference patch |
| Cohort 3 | Placebo comparator | Placebo patch. Receives: Drug: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
AEs will be collected from the start of randomization throughout the treatment period up to and including the Follow-up Visit. Any AE that is ongoing at the last visit will be followed up as appropriate. Serious AEs will be recorded from the time of informed consent. Local skin sensations will be assessed by asking about injection site sensations (sensation experienced before removal of the patch), this will be rated on a four-point scale: none, mild, moderate or severe. Skin reactions will be performed after removal of the patch to inspect the area which has been in contact with the cream and the patch. Two separate assessments will be made - one for the skin in contact with the cream and one for the skin which had been in contact with the adhesive border.
Measured: From randomization until test procedure 2 or last study visit, whichever is later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start30 Oct 2017
- Primary completion9 Nov 2017
- Study completion9 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Dr. med.Rainard Fuhr, Principal investigator, PAREXEL Early Phase Clinical Unit Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313336
- Sponsor's protocol ID
- D069GC00001
- Acronym
- EMLA
- Status last verified
- Nov 2017
- First submitted
- 8 Sep 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, 2-period, Placebo-controlled, Single-center, Crossover Study to Assess the Therapeutic Equivalence of the EMLA Current Reference Patch and the EMLA Test Patch in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03313336
- Acronym / sponsor ID
- EMLA / D069GC00001
- Conditions
- Pain
- Keywords
- Dermal anesthesia., Venipuncture and intravenous cannulation., Skin blanching or erythema., Phase I., Therapeutic equivalence., Eutectic Mixture of Local anaesthetics (EMLA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 9 Nov 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 VAS. Visual analogue scale (VAS) as a research tool is frequently used for the assessment of pain severity and relief. VAS is easy to use and can be applied in a variety of settings; results are reproducible. VAS data are sensitive to treatment effects and can be analyzed using parametric statistical techniques. 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. There will be a washout period of at minimum of 4 calendar days between treatment periods (visits). No follow-up visit is needed. Any adverse event (AE) that is ongoing at the last visit will be followed up as appropriate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: EMLA test patchEMLA Test Patch. |
| Cohort 2 | Active comparator | Drug: EMLA current reference patchEMLA Reference Patch. |
| Cohort 3 | Placebo comparator | Drug: Placebo PatchPlacebo patch. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMLA test patchEMLA® 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 | Cohort 1 |
| EMLA current reference patchEMLA 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 | Cohort 2 |
| Placebo PatchPlacebo 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. | Drug | Cohort 3 |
Primary outcome
Comparison of anesthetic efficacy of EMLA Test Patch with the marketed EMLA patch (EMLA current Reference Patch) by pain reduction assessment.
Time frame: At test procedure 1 and at test procedure 2 (which is after 4 days of washout period following test procedure 1).
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).
1 secondary outcome
Number of participants with Adverse events (AEs), skin sensation and reactions as variables of safety and tolerability.
Time frame: From randomization until test procedure 2 or last study visit, whichever is later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Pain
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
RecruitingPhase 4
Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
Opioid Use, Fractures, Bone
Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Pain Catastrophizing, Pain, Chronic
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. med.Rainard Fuhr principal investigator
PAREXEL Early Phase Clinical Unit Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EMLA test patch and EMLA current reference patch in people with Pain, run by AstraZeneca at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of anesthetic efficacy of EMLA Test Patch with the marketed EMLA patch (EMLA current Reference Patch) by pain reduction assessment. (time frame: At test procedure 1 and at test procedure 2 (which is after 4 days of washout period following test procedure 1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.