Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03313336 | A Study to Assess Therapeutic Equivalence Between Test EMLA Patch With Marketed EMLA Patch in Healthy Subjects. | PHASE1 | COMPLETED | 32 | — | — | Oct 30, 2017 | Nov 9, 2017 | Nov 14, 2017 | 1 | Germany |
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).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | ACTIVE_COMPARATOR | EMLA Test Patch. |
| Cohort 2 | ACTIVE_COMPARATOR | EMLA Reference Patch. |
| Cohort 3 | PLACEBO_COMPARATOR | Placebo patch. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and female subjects aged 18 to 60 years. 3. Have healthy skin over hands, with no inflammation or open wounds. 4. Able to understand, read and speak the German lang...