E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The management of cancer pain in patients on step 3 of the WHO analgesic ladder, ie patients on a regular opioids for moderate to severe pain and paracetamol. |
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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 |
The primary objective is to establish how many patients choose to restart their paracetamol having been asked to discontinue it, at completion of the study (day 7). |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are: 1. To assess changes in pain scores from baseline on day 2 and day 7 after stopping paracetamol. 2. To establish which groups of patients, or types of pain, benefit from continuing paracetamol.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Clinical diagnosis of cancer. 2. Age ≥18yr. 3. Taking regular opioids for moderate to severe pain (i.e. 4hrly normal release opioid; 12hourly modified release opioid; or a transdermal patch - step 3 of the WHO analgesic ladder) for the preceding 7 days. 4. Taking ≥ 2g / day paracetamol for the preceding 7 days. 5. Average pain score for the preceding 24hrs ≤4 on a 0-10 numerical rating scale (NRS).
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E.4 | Principal exclusion criteria |
1. Unwilling to stop paracetamol 2. No diagnosis of malignant disease. 3. Age <18yr. 4. Prognosis <2weeks. 5. Radiotherapy treatment in the preceding 4 weeks. 6. New anti-cancer treatment in the preceding 4 weeks. 7. Average pain score for the preceding 24hrs ≥5 on NRS. 8. Significant cognitive impairment, i.e. unable to complete pain questionnaire.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the number of patients choosing to re-start their paracetamol at the end of the study (day 7). |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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 end of the trial is defined as the last visit/telephone call of the last patient. |
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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 |