E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
Malnutrition, poor appetite, kidney function in older medical patients |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061273 |
E.1.2 | Term | Malnutrition |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002646 |
E.1.2 | Term | Anorexia |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061428 |
E.1.2 | Term | Decreased appetite |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10056720 |
E.1.2 | Term | Muscle mass |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053349 |
E.1.2 | Term | Pharmacokinetic study |
E.1.2 | System Organ Class | 10022891 - Investigations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018355 |
E.1.2 | Term | Glomerular filtration rate |
E.1.2 | System Organ Class | 10022891 - Investigations |
|
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 CanPAN trial consists of two studies each with a primary objective
- Study 1: To investigate if Sativex® has appetite stimulating properties defined as increased energy intake compared to placebo
-Study 2: To compare the performance of kidney function estimates based on endogenous biomarker(s), creatinine clearance (24 hours urine collection) and measured GFR (mGFR) for predicting gentamicin clearance. |
|
E.2.2 | Secondary objectives of the trial |
The CanPAN trial consists of two studies each with secondary objectives
- Study 1: To develop a pharmacokinetic-pharmacodynamic model, gain knowledge about the effects of Sativex® on other markers of appetite and safety parameters and on the intraocular pressure
- Study 2: If the predictive accuracy of the pharmacokinetic modeling of gentamicin differs between GFR estimates, creatinine clearance and mGFR. Correlation coefficient between clearance gentamicin and clearance eGFR/creatinine clearance/mGFR.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
≥70 years Admitted to the Department of Emergency Medicine, Hvidovre Hospital Can cooperate cognitively Risk of malnutrition defined by NRS-2002 score ≥3 Low appetite / age-related anorexia measured with SNAQ score ≤14 BMI ≤25 Must be able to read and understand Danish Postmenopausal defined as missed periods for at least 12 months before the start of the trial |
|
E.4 | Principal exclusion criteria |
Regular use of medical cannabis (patient reported) Use of medical cannabis within 14 days at baseline (patient reported) Recognized or suspected psychotic illness in the subject or his family (medical record and patient report) Severe personality disorders (journal) Significant psychiatric disorder in addition to mild to moderate depression (journal) Allergy to the ingredients of Sativex®, placebo and Hexamycin® (patient reported) Terminal diagnosis (journal) Cancer disease (journal) Liver transplant (journal) Chronic eGFR ≤15 mL / min2 or dialysis treatment (journal) Pacemaker (journal) Epilepsy (journal) Recurrent seizures (journal) Severe cardiovascular disease NYHA IV (journal) Previous heart attack (journal) Uncontrolled hypertension (journal) Cardiac arrhythmias (journal) Food intolerance to the ingredients in the test meals (patient reported) Vegetarian and vegan (patient reported) Unwilling to avoid driving for up to 72 hours after administration of Sativex® (patient-reported) Unwilling to avoid alcohol 24 hours up to the trial days (patient reported) Patients with ascites (medical record) Patients with significant edema on the days of the trial (medical record / visual inspection) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The CanPAN trial consists of two studies each with a primary endpoint
- Study 1: Difference in energy intake (kJ) measured at a test meal between Sativex® and placebo
- Study 2: If the predictive accuracy of the pharmacokinetic modeling of gentamicin differs between the use of eGFR panel and mGFR. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Study 1: Difference in energy intake (kJ)between Sativex® and placebo on testday 1 and testday 2.
Study 2: The day of Gentamicin administration. |
|
E.5.2 | Secondary end point(s) |
The CanPAN trial consists of two studies each with secondary outcomes - Study 1: Population-based pharmacokinetic-pharmacodynamic modeling of Sativex® and its metabolites Difference in appetite as a combined appetite score measured on VAS between Sativex® and placebo Difference in the appetite hormones total ghrelin and GLP-1 between Sativex® and placebo Differences in eating patterns measured by Satorius' weight and mathematical modeling between Sativex® and placebo Safety parameters (CNS effects, cognition, balance disorders, blood pressure and heart rate) for Sativex® Difference in the intraocular pressure between Sativex® and placebo
- Study 2 If the predictive accuracy of the pharmacokinetic modeling of gentamicin differs between eGFRkreatinin, eGFRcomb, eGFRpanel, creatinine clearance and mGFR as covariate. Correlation coefficient between clearance gentamicin and clearance eGFR/creatinine clearance/mGFR. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Study 1: - Measured between Sativex® and placebo on testday 1 and testday 2 - Difference in appetite as a combined appetite score measured on VAS between Sativex® and placebo Difference in the appetite hormones total ghrelin and GLP-1 between Sativex® and placebo Differences in eating patterns measured by Satorius' weight and mathematical modeling between Sativex® and placebo Safety parameters (CNS effects, cognition, balance disorders, blood pressure and heart rate) for Sativex® Difference in the intraocular pressure between Sativex® and placebo - Measured after administration of Sativex - Population-based pharmacokinetic-pharmacodynamic modeling of Sativex® and its metabolites
Study 2 - The day of Gentamicin administration. |
|
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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Pharmacokinetic, pharmacodynamic trial and therapeutic exploratory |
|
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) | 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.8.5 | 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
|
|
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 |