E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who have neuropathic pain related to cancer and/or treatment for cancer (surgical, chemotherapy or radiotherapy) which has resulted in neuropathic pain. |
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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 | 10059513 |
E.1.2 | Term | Palliative care |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 3.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033470 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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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 establish whether ketamine given in addition to best standard pain management improves malignant neuropathic pain compared to best standard pain management alone. |
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E.2.2 | Secondary objectives of the trial |
(a) to compare initial treatment benefit using the sensory component of the McGill Short Form Questionnaire; (b) to compare difference in overall pain between the study arms based on the VAS score; (c) to compare difference in neuropathic pain between the study arms based on the LANSS pain scale; (d) to compare patient distress between the two arms based on NCCN Distress Thermometer; (e) to assess the side-effects and tolerability of trial drug and (f) to assess the effect of intervention on quality of life scores, anxiety and depression (based on HAD scale) and opioid requirements. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• > 18 years of age • Patient has a histological proven cancer diagnosis • Written informed consent (to be obtained within 28 days prior to entry into the study) • Index neuropathic pain (as defined by LANSS) that is related to underlying malignancy or resulting from treatment received for this • Index neuropathic pain >= 4 on 0-10 (VAS) • McGill Sensory Scale Score > 5 • Patient has had a trial of at least one adjuvant analgesic (gabapentin, pregabalin, amitriptyline) or has been offered these and declined • Patient is able to comply with study procedures
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E.4 | Principal exclusion criteria |
• Patients who have received chemotherapy or radiotherapy in the preceding six weeks that is likely to affect neuropathic pain • Patients who may have a change in tumoricidal treatment during the period of the study that is likely to alter pain during the course of the study • Diastolic blood pressure > 100mmHg at screening • History of seizures in last 2 years • Patient is currently taking class I anti-arrhythmic drugs • Life expectancy less than two months • Patients who are actively hallucinating • Women of childbearing potential who are not using adequate contraception • Patients with cerebrovascular disease (strokes) • Patients with psychotic disorders or cognitive impairment
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E.5 End points |
E.5.1 | Primary end point(s) |
To establish whether ketamine given in addition to best standard pain management improves malignant neuropathic pain compared to best standard pain management alone. This is assessed using the sensory component of the McGill Short Form Questionnaire. |
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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 | Yes |
E.6.10 | Pharmacogenetic | Yes |
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 | No |
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 | 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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For the purposes of Clinical Trial Authorisation the trial is deemed to have ended 30 days after the last patient remaining on treatment received the last dose of ketamine or placebo. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |