E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The condition under investigation is neuropathic-type pain. This may be due to a variety of causes including malignant neuropathic-type pain (such as tumour-related nerve compression or cancer-related bone pain) or chemotherapy induced neuropathy. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054095 |
E.1.2 | Term | Neuropathic pain |
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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 |
The primary outcome measure is whether 1% topical menthol provides clinically significant pain relief in patients with pain with a neuropathic element. The hypothesis being tested is whether TRPM8 channels have an important analgesic role in clinical neuropathic pain states. |
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E.2.2 | Secondary objectives of the trial |
The secondary outcome measures are the effects of topical menthol on other components of pain perception such as mood, function and general sensation. We aim to establish whether particular aspects of pain will respond better to this form of treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Patients with neuropathic-type pain. 2.Male or female aged 18 years or over at study entry. 3.Patients whose usual medical team agree to their taking part in the study. 4.Patients who provide written consent to participation in the study after explanation of the study protocol. 5.Patients who consent to the relevant parts of their medical notes being accessed by the Research Team. 6.Patients who, in the opinion of the investigator, are willing and able to attend as an outpatient and are able to complete the various assessments. 7.Patients need to have the ability to complete questionnaire assessments in English language. |
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E.4 | Principal exclusion criteria |
1.Patients with any contraindication to the use of topical therapy or menthol. 2.Patients who are confused or suffering from significant psychiatric illness, which would hinder their completion of the study. 3.Patients whose condition is unstable or rapidly deteriorating, such that they are unlikely to be able to contribute to the study. 4.Patients with any other medical condition that would confound the objectives of the study. 5.Patients who would be adversely affected by study participation. This would include those who find completion of the study too burdensome. 6.Patients who, in the opinion of the Research Team or their usual medical team, would be unable to complete the study protocol for any other reason. 7.Patients who are unable or refuse to provide written consent to inclusion in the study after explanation of the study protocol.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome will be assessed at the 4 – 6 week visit. A clinical response will be defined as a reduction of two or more points of worst pain on the 0-10 Visual Analogue Scale between baseline and this 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 | 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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| 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 | 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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For the purposes of Clinical Trial Authorisation the trial is deemed to have ended 30 days after the last patient completes the final study assessment. For the purposes of REC approval, the study end date is deemed to be the date of the last data capture. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 |