E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced cancer patient with severe cancer pain |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033371 |
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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 objective of this study is to compare the tolerability profile of controlled release oxycodone to controlled release morphine during the first 14 days of administration for the treatment of moderate to severe chronic oncological pain. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are to compare the two above mentioned treatments in terms of efficacy in pain reduction, tolerability and efficacy in elderly patients age 70 years , tolerability and efficacy in patients with renal impairment creatininemia levels 1.2 mg/dl and 3 mg/dl . |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The following is the patient profile criteria Patients older than 18 years of age, patients with oncological referred pain within the 24 hours preceding the initial administration of treatment with an intensity of greater than or equal to 5 measured by the numerical scale NRS of 11 levels 0-10 , patients who did not take other analgesics or who only took NSAIDs and/or weak opioids either I or II on the WHO scale , patients have given their written consent, patients in the study have been given at least one month to live, patients are required to follow the treatment regiment for at least 2 weeks under clinical observation, patients with KPS greater than or equal to 40. |
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E.4 | Principal exclusion criteria |
Patients with one or more of the following criteria are not appropriate patients for this type of study Treatment with morphine, oxycodone, buprenorphine, fentanyl, or methadone in the 30 days leading up to the study. Patients whose medical history, based on the opinions of a physicians, is significant for intolerance to morphine or oxycodone Patients whose doctors have suggested they should add ex novo another analgesic adjuvant steroids, anticonvulsants, antidepressants Patients with severe renal impairment Patients with moderate to severe hepatic insufficiency Patients with dispnea or severe BPCO Patients who are not able to be treated taking oral medications as recommended by the WHO guidelines Patients who have a history of ongoing psychiatric illness Patients with cognitive deficit that cannot consent to the treatment and will not comply with the treatment protocol Patients with cerebral metastasis Patients who are either pregnant or breast feeding. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome variable is the dichotomous variable that indicates a worsening, in the first 14 days of treatment, of at least one of the following adverse effects nausea, vomiting, hallucinations, mental confusion, constipation, sedation, dry mouth, itching. The patient was defined to have deteriorated if, in respect to the base-line evaluation, he registered a worsening of at least 2 points of a scale of 0 to 10 for at least one of the symptoms considered and for at least one of the two weeks of treatment. For hallucinations the worsening is indicated by the presence of at least one episode during the two weeks of 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 | 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 | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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.8.5 | 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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |