E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic painful neuropathy |
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E.1.1.1 | Medical condition in easily understood language |
Nerve damage with pain in patients with diabetes |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
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 |
We propose to test, in patients with diabetes and chronic nerve pain, the effects of repeated applications of capsaicin 8% patch on pain, sensory tests, and the potential to repair the nerve fibre damage in serial skin punch biopsies.
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to determine the effectiveness of repeated applications of capsaicin 8% patch in 1. Reducing areas of increased sensitivity or numbness in the skin, assessed using a) cotton wool, b) brush, c) monofilaments (nylon hairs), d) pinprick and e) temperature sensation; 2. Improvement of different pain characteristics using the McGill pain questionnaire; 3. Improving the Patient Global Impression of Change (PGIC).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Participants aged 18-80 years with painful distal, symmetrical, sensorimotor polyneuropathy due to type 2 Diabetes of at least 1-year duration. 2. Stable control for at least 3 months of type 2 Diabetes mellitus. 3. Glycosylated haemoglobin (hbA1c) of ≤ 9%. 4. Willing to provide written informed consent to participate in the study. 5. Patients with a history of pain intensity equal or greater than 4 NPRS points (as determined by the NPRS study diary at baseline) are eligible to participate.
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E.4 | Principal exclusion criteria |
1. Non-diabetic neuropathies 2. History of alcohol/substance abuse 3. History of severe psychiatric illnesses 4. Pregnancy/breast feeding or planning pregnancy during the course of the study 5. Significant renal impairment (eGFR <30mL/minute/1.73m2) 6. Heart failure New York Heart Association (NYHA) ≥ class II 7. Any other painful medical conditions that may interfere with the assessment of change in neuropathic pain.
In addition to the exclusion criteria above patients who are participating in another clinical trial or who have done so within 30 days before screening will be considered as not eligible for the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The outcome measures will include confirmation of overall reduction in mean NPRS pain score at the site of capsaicin 8% patch, and this will be related to skin biopsy markers, particularly PGP9.5 and GAP-43 density in the dermis, to assess nerve repair and regeneration (disease modification), which is the aim of this study. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Sensory testing, patient global impression of change (PGIC). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard of care (SOC) alone |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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Subjects will be considered complete for the purpose of this study once they have completed all procedures at the end of follow-up study visit. The end of the study is defined as the last visit of the last subject undergoing the study. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 | 1 |