E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
In this study the effect of transdermal lidocaine in patients with painful peripheral diabetic neuropathy will be examined.
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MedDRA Classification |
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 test the hypothesis that mechanical hyperalgesia and allodynia in patients with painful diabetic neuropathy (assessed before treatment using quantitative-sensory testing) is partly reversed during the chronic treatment with transdermal lidocaine. |
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E.2.2 | Secondary objectives of the trial |
- To test the hypothesis that increased thermal perception threshold in patients with painful diabetic neuropathy (assessed before treatment using quantitative-sensory testing) is correlated with the degree of pain reduction during the treatment with transdermal lidocaine compared to diabetic patients with decreased thermal perception thresholds. Are patients with increased thermal thresholds less responsive than those with decreased thresholds and thus allow discrimination of treatment responders and non-responders? - To test the hypothesis that chronic treatment with lidocaine 5% plaster causes epidermal nerve degeneration.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- subjects of at least 18 years of age; - subjects who have given there written informet consent; - at baseline female subjects of child bearing potential must be using adequate contraception and must have a negative urine pregnancy test; - pain due to peripherial polyneuropathy at the lower extremities with duration of > = 3 months, whose pain is not adequately controlled (subjects with average pain of >= 4 on a numerical rating scale( 0-10), 0 is no pain, 10 is worst imaginable pain) - intact skin surfacen at the potential patch application sites |
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E.4 | Principal exclusion criteria |
- pregnant or brest feeding subjects - contraindications to versatis - patiens with severe cardiac disorders ( NYHA >3) - subjects with alcohol or drug abuse or addictive personality - subjects with significant psyciatric disorder - subjects receiving antipsychotic medication - subjects for whom a treatement could alter the degree or nature of pain - subjects who received investigational drug or used investigational device in thirty days prior to studie entry -subjects known to have a condition that in the investigators judgement precludes participation in the studie - subjects unable to comply with the study assessments and to complete the questionnaires - subjects with peripheral vascular disease ≥ III following the Fontaine Classification - subjects with history of slow-healing diabetic foot ulcers or current skin or soft tissue lesions on the foot that will interfere with application of the lidocaine patch and or skin biopsies
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E.5 End points |
E.5.1 | Primary end point(s) |
Global patients teatment satisfaction, which is measured as a combination parameter of analgesic efficacy of treatment plus its tolerability, is defined as primary and endpoint variable throughout the study. This global treatment satisfaction is quantified by use of a validate 5-point verbal rating scale, judging the quality of treatment ( from the patients point of view) as either very good, good, satisfactory, poor or as inadequate. Patients who judge their treatment during the study period (on average) at least as good, are considered as good treatment responders for the primary endpoint evaluation. |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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 undergoing the trial |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |