E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Local anesthetics for minor or more major procedures such as suturing lacerations, removing skin lesions, operating ingrown toenails, drilling and removing teeth etc. |
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E.1.1.1 | Medical condition in easily understood language |
Local anesthetics for procedures such as suturing lacerations, removing skin lesions, operating ingown toenails, drilling and removing teeth etc. |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024760 |
E.1.2 | Term | Local anesthetic |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To identify if a decreased or absent effect of local anesthetics in producing skin anesthesia is present in a group of patients by measuring sensitivity for light stroking, pinprick, warm, cold and possible warm and cold pain using objective sensoric tests.
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety profile of Lidocain by reporting of Adverse Events with a possible/probable relationship to the study medication. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age 18-65
• Patient report of a decreased effect of local anesthetics,
• Signed informed consent
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E.4 | Principal exclusion criteria |
• Previous adverse reaction to local anesthetics (not including decreased effect)
• Injury, infection or peripheral nerve injury in the experimental sites
• Diabetes or medical conditions not suitable for participation in the study
• Use of anticoagulants
• Difficulty to understand written and spoken Swedish.
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E.5 End points |
E.5.1 | Primary end point(s) |
Measuring changes in sensitivity for
• light stroking
• pinprick
• warm, cold and possible warm and cold pain: Quantitative sensory testing (QST).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The first sensory testing will be done before injection and will then be repeated six times, i.e. every 10 minutes during one hour.
Quantitative Sensory Testing (QST): With a thermode connected to a computer that cycles warm or cold temperatures to a skin region, these can be tested. From a baseline of 32oC, temperatures are increased or decreased by 1oC/sec. to a maximum of 50oC for warmth and a minimum of 10oC for cold. The subjects indicate with a handheld switch. |
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E.5.2 | Secondary end point(s) |
Number of Adverse Events / Serious Adverse Events with possible or probable relationship to the study medication. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From administration of lidocaine until end of study, or until the patient reports an event occurring after study visit. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |