E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 evaluate the analgesic efficacy of Sativex compared with placebo, when added to existing treatment regimens, in relieving pain due to diabetic neuropathy (DN). |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of Sativex® compared with placebo on:
Secondary measures of pain relief Brief Pain Inventory (BPI) Subject Global Impression of Change Sleep quality
To assess the safety and tolerability of Sativex®
Tertiary Objective: To evaluate the effect of Sativex® compared with placebo on:· Quality of life assessments (Pain Disability Index, EQ-5D, SF-36) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion: subjects meeting the following criteria will be considered eligible for this study: 1. Subjects aged 18 years or above. 2. Type 1 or 2 diabetes mellitus diagnosed according to the WHO criteria. 3. Diagnosed with neuropathic pain due to distal symmetrical diabetic neuropathy of at least six months duration, as defined by a Neuropathy Disability Score of at least 4, and in whom pain is not wholly relieved with their current therapy. N.B., a score must be attained from at least two different test parameters and not only the ankle jerk reflex. 4. Subject has at least moderate neuropathic pain due to distal symmetrical diabetic neuropathy, which is defined by: NRS pain scores on all of baseline days B2 to B7 have been recorded, via the IVRS, by the subject and sum to at least 24. 5. Subject fulfils at least one of the two criteria below. Subject must be either:- -Currently established on a regular dose of analgesic therapy for their pain due to diabetic neuropathy. -Previously tried and failed or could not tolerate analgesic therapy for their pain due to diabetic neuropathy. 6. Stable medication regimen for at least 2 weeks prior to study entry, for all medications that may have an affect on neuropathic pain, except paracetamol/acetaminophen. 7. Subject is willing to stop taking their own paracetamol/acetaminophen or paracetamol/acetaminophen containing medications and start using study medication paracetamol/acetaminophen as required (prn) for the duration of the study. 8. Subject is willing to maintain a stable dose of medications that may have an effect on neuropathic pain, other than study medication and paracetamol/acetaminophen, for the duration of the study. |
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E.4 | Principal exclusion criteria |
Exclusion: The subject may not enter the study if ANY of the following apply:· 1. Subject has uncontrolled diabetes with HbA1c blood levels of more than 11% at Visit 1, Day B1. 2. Subjects, whose identified pain is likely to be of a nociceptive, musculoskeletal, central neuropathic or psychogenic origin. 3. Concomitant pain thought by the investigator to be of a nature or severity to interfere with the subject’s assessment of their pain due to diabetic neuropathy. 4. Currently receiving a prohibited medication and unwilling to stop or comply for the duration of the study. 5. Currently using or has used recreational cannabis, medicinal cannabis (including Sativex), or synthetic cannabinoid based medications within 3 months prior to study entry and unwilling to abstain for the duration for the study. 6. Any known or suspected history or family history of schizophrenia, or other psychotic illness; history of severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition. 7. Significant cardiac, renal or hepatic impairment. 8. If female, is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter. 9. Travel outside the country of residence planned during the study. 10. Subjects who have received an Investigational Medicinal Product within the 12 weeks before the screening visit. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the mean 11-point numeric rating scale (NRS) diabetic neuropathy pain score at the end of treatment (usually week 14).
The variable for analysis will be the change in mean NRS from baseline to the end of the treatment. |
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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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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.8.3 |
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 | 24 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 51 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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The last subject to complete visit 7 |
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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 |