E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
to improve weight change resulting from tumour cachexia |
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E.2.2 | Secondary objectives of the trial |
• body mass index (BMI) • effect on compartmentalisation. • effect on appetite of patients (VAS). • Calorie count of food intake • effect on quality of life of patients (EORTC QLQ C30) • patient’s judgement / global satisfaction • investigator’s judgement, clinical global impression scale (CGI) • effect on pain during study (consumption of analgesics, if applicable) • safety/tolerance, • death rates in both groups during the 16 weeks following to inclusion in the study (optional)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with tumour cachexia as patients with a loss of 3% or more of body weight during a period of up to 8 weeks preceding inclusion and fulfilling all in- and exclusion criteria Patients with the following diagnosis according to ICD-10 are eligible: N. Bronchi, C 34.9, no CNS metastases
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E.4 | Principal exclusion criteria |
• life expectancy < 2 months • subjects who are not available over a period of at least 8 weeks, • suspected ileus or other intestinal disorders including gastritis or bowel dysfunction • pancreatitis or pancreatic cancer • any known abuse of marijuana or a history of abuse of marijuana • serious concomitant medical illness/concomitant disease(s) which would preclude the patient from participating (e.g., serious psychiatric illness that would interfere with obtaining informed consent etc.), • participation in an experimental trial within the last 4 weeks • subjects where no written informed consent is received • female subjects of child bearing potential in which a pregnancy has not been ruled out by appropriate tests (fertile women must practice adequate contraception throughout the course of the study); • lactation
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | No |
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) | 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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |