E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058019 |
E.1.2 | Term | Cancer pain |
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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 trial is to evaluate the efficacy of Morphine Egalet® formulation 30-240 mg once daily compared to MST Continus 15-120 mg twice daily after 2 weeks of treatment. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this trial is to evaluate the safety and tolerability of Morphine Egalet® formulation compared to MST Continus after 2 weeks of treatment. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
PK sampling addendum to protocol MP-EG-002 Addendum 1 Final version, 19 December 2006
The objective of this sub-study is to evaluate the correlation between intensity of hourly sedation as reported by the patients and the plasma concentration of morphine and its metabolites. |
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E.3 | Principal inclusion criteria |
1. The patient has stable strong opioid use equipotent to 30-240 mg oral morphine sulphate daily for a minimum of 2 weeks prior to entering the run-in phase. 2. The patient has opioid-sensitive pain caused by active cancer. 3. The patient is aged minimum 18 years. 4. The patient has the ability to comprehend and communicate effectively with the Investigator and staff. 5. The patient has provided written informed consent. 6. The patient has the ability to comply with all trial requirements.
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E.4 | Principal exclusion criteria |
1. The patient has a life expectancy less than 2 months. 2. The patient has received chemotherapy less than 4 weeks prior to entering run-in phase 3. The patient has received radiation therapy less than 4 weeks prior to entering run-in phase 4. The patient plans to undergo radiation or chemotherapy or other non-pharmacological treatments with potential analgesic effect during the study. 5. Patients with medical conditions contraindicating morphine treatment: known hypersensitivity to morphine or any other component of the study drug, severe broncial asthma or obstructive airway disease, respiratory depression, increased intracranial pressure, paralytic ileus or gastrointestinal obstruction. 6. The patient has untreated psychiatric disease. 7. The patient has hepatic disease defined as a Child-Pugh score > 9 (i.e., Class C). 8. The patient has impaired kidney function (creatinine clearance less than 60 mL/min reported by the central laboratory). 9. The patient has a hematocrit less than 0.30. 10. The patient has a condition severely affecting gastrointestinal absorption. 11. The patient is taking monoamine oxidase inhibitors (MAOIs) or has taken a MAOI within two weeks prior to entering baseline. 12. The patient is taking other opiod agonists or antagonists, zidovudine or cimetidine. 13. Patients taking benzodiazepines, barbiturates, phenothiazines, chloralhydrat or tricyclic antidepressants can only be included if the dose has been stable for 2 weeks pritor to the randomization visit and if the dose is expected to remain stable throughout the study. 14. The patient has a current alcohol or drug abuse or a history of alcohol or drug abuse within the past 24 months. 15. Pregnant or lactating women. Female subjects of childbearing potential must use an adequate form of contraception (i.e., oral contraceptive pill, hormonal implant, IUD or double barrier method) and have a negative urine pregnancy test at screening.
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E.5 End points |
E.5.1 | Primary end point(s) |
Use of rescue medication. The patient will record each dose (number of capsules and time of dosing) in the patient diary during the run-in phase and each treatment phase. Use of rescue medication on the last 7 days of each treatment period (exclusive the visit day) will be used for the efficacy analysis. Use of rescue medication during the last 3 days of the run-in phase will serve as statistical baseline for both treatment periods. |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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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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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |