E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of neuropathic cancer pain. |
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E.1.1.1 | Medical condition in easily understood language |
Treatment of cancer pain. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 see whether the addition of low-dose ketamine to a subcutaneous morphine infusion improves analgesia in patients with refractory neuropathic cancer pain. |
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E.2.2 | Secondary objectives of the trial |
To see whether the addition of low-dose ketamine to a subcutaneous morphine infusion improves analgesia in patients with refractory neuropathic cancer pain. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18-70 years.
Patients are admitted to hospital
Cancer pain judged to have a neuropathic component.
Clinically normal renal and hepatic function.
Patients are able to cooperate and understand information.
”Worst” pain at rest or on movement is 5 or more (NRS 0-10).
The pain is currently treated with continuous subcutaneous morphine infusion.
The daily morphine dose is ≥48mg/24 hours and a 30% increase in the daily dose has not provided sufficient pain relief.
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E.4 | Principal exclusion criteria |
Reduced renal or hepatic function.
Suspicion of morphine toxicity (sedation, hallucination, myoclonus, increasing pain).
Increased intracranial pressure (suspicion of cerebral metastases) or cerebral metastases.
Unable to cooperate/ understand information.
”Worst” pain at rest or on movement < 5 on NRS.
Current treatment with other opioids than morphine.
The patient is undergoing radiotherapy in the pain area, or has received radiotherapy in the pain area within the last four weeks.
Changes in the use of analgesics (paracetamol, NSAIDS), adjuvant drugs (antidepressants, antiepileptics, corticosteroids, muscle relaxants) or their dosages less than 2 days prior to inclusion or during the study period.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in pain intensity compared to baseline. Significant reduction in pain intensity will be defined as at least 30% reduction in Numeric Rating Scale (NRS) score compared to baseline. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 4 days of treatment; 2 days with Ketalar and 2 days with placebo; the endpoint will be evaluated. |
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E.5.2 | Secondary end point(s) |
Decrease in on-demand morphine consumption. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 4 days treatment of the patient we will evaluate this endpoint. |
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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 | 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 | 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 | Yes |
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.8.2.4 | 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 | 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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End of the trial is when we have included and treated 20 patients, each patient included/treated for only 4 days. |
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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 | 0 |