Aging Clinical Trial
— CanPanOfficial title:
A Pharmacological Trial With Sativex® and Gentamicin for Optimized Phamacological Treatment of Older Patients With Focus on Appetite Stimulation and Renal Risk Drugs
Malnutrition and inappropriate prescribing of renally excreted drugs are common among older persons and are associated with severe consequences such as complicated courses of treatment, mortality, and reduced quality of life. The overall purpose of CanPan is to optimize treatment of older persons with malnutrition with a focus on appetite stimulation and optimized prescribing of renal risk drugs. The CanPan trial consists of two sub-studies. Substudy 1 will provide knowledge on appetite and appetite stimulation and together, sub study 1 and 2 will offer unique knowledge on how body composition, renal function and biomarkers of organ function influence pharmacokinetics for a highly lipophilic (Sativex®) and hydrophilic (Hexamycin®) drug in older medical patients with malnutrition.
Status | Recruiting |
Enrollment | 17 |
Est. completion date | September 1, 2023 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - =65 years of age - Admitted to the acute medical department, Hvidovre Hospital - Can cooperate cognitively and physically (patient reported) - Low appetite/anorexia of ageing measures by SNAQ score =14 - BMI =30 (screening) - Able to read and understand Danish - Postmenopausal defined as missed periods for at least 12 months before the start of the trial 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 the subjects family (medical record and patient report) - Severe personality disorders (journal) - Significant psychiatric disorder in addition to mild to moderate depression (medical record) - Allergy to the ingredients of Sativex®, placebo and Hexamycin® (patient reported) - Terminal diagnosis (journal) - Liver transplant (journal) - Chronic eGFR =15 mL / min2 or dialysis treatment (medical record) - High risk of nephrotoxicity due to existing drug treatment (medical assessment) - Pacemaker (journal) - Epilepsy (journal) - Recurrent seizures (journal) - Uncontrolled hypertension (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 test days (patient-reported) - Patients with ascites ( journal) - Patients with significant edema on the days of the trial (journal / visual inspection) - In active treatment of cancer or have disseminated cancer (journal) - Known with brain - or kidney tumor (journal) - Known with angina pectoris or intermittent claudication - Known with stroke, AMI, or heart failure (NYHA III-IV) within the past 5 years (journal) - In isolation - Obs. Covid-19 |
Country | Name | City | State |
---|---|---|---|
Denmark | Clinical Research Centre | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Ove Andersen | Glostrup University Hospital, Copenhagen, North Denmark Regional Hospital, Region Hovedstadens Apotek, University Hospital Bispebjerg and Frederiksberg, University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in energy intake (kJ) between Sativex® and placebo | Measured at test meal | Trial days 1 and 2. | |
Primary | Differences in the objective function value of the population-based pharmacokinetic model when implementing renal clearance assessed by measured GFR (mL/min), or GFR estimates based on different endogenous markers, as covariates on gentamicin clearance | The objective function value (minus two times the log-likelihood) describes the prediction accuracy (goodness-of-fit) of a population pharmacokinetic model. A drop in the objective function value of 6.63 in a model with one (1) added covariate implemented on any specific parameter compared to a base model corresponds to a significant improvement in model fit with a p-value of 0.01 in a chi-squared test.
Population-based pharmacokinetic modelling is an analysis method performed on pharmacokinetic data, i.e., plasma concentrations over time. Relevant pharmacokinetic parameters are estimated simultaneously by fitting the data to the model. The model structure is found through the analysis and determines which pharmacokinetic parameters are estimated. As a minimum, the clearance and distribution volume of the central compartment are estimated |
Trial day 3. | |
Secondary | Differences in the objective function values of the population-based models of CBD and THC when implementing bodyweight, age, and body composition factors as covariates on the pharmacokinetic parameters of the model (e.g., clearance) | The objective function value (minus two times the log-likelihood) describes the prediction accuracy (goodness-of-fit) of a population pharmacokinetic model. A drop in the objective function value of 6.63 in a model with one (1) added covariate implemented on any specific parameter compared to a base model corresponds to a significant improvement in model fit with a p-value of 0.01 in a chi-squared test.
Population-based pharmacokinetic-pharmacodynamic modelling is an analysis method performed on pharmacokinetic data, i.e. plasma concentrations over time, coupled to pharmacodynamic data. Relevant pharmacokinetic and -dynamic parameters are estimated simultaneously by fitting the data to the model. The model structure is found through the analysis and determines which pharmacokinetic and -dynamic parameters are estimated. As a minimum, the clearance and distribution volume of the central compartment are estimated |
Trial days 1 and 2. | |
Secondary | Difference in subjective appetite between Sativex® and placebo | Using combined subjective appetite scores measured using 100-mm Visual Analogue Scales (VAS), with 0.0 as the minimum value and 10.0 as the maximum value. The following will be used to calculate a combined appetite score: [desire to eat + hunger + prospective food consumption + (10.0 - fullness) + (10.0 - satiety)], with higher scores indicating better appetite. | Trial days 1 and 2. | |
Secondary | Differences in the appetite hormones, total ghrelin and glucagon like peptide 1 (GLP-1) between Sativex® and placebo | The appetite hormones (total ghrelin, GLP-1) is measured from blood samples | Trial days 1 and 2. | |
Secondary | Change in the intraocular pressure of the eye between Sativex® and placebo | Measured by Icare ic100 tanometer | Trial days 1 and 2. | |
Secondary | Safety parameter (CNS effects) for Sativex® | Measured using 100-mm Visual Analogue Scales (VAS), with 0.0 as the minimum value and 10.0 as the maximum value. Higher scores indicate a larger effect. | Trial days 1 and 2. | |
Secondary | Safety parameter (cognition) for Sativex® | Measured using Hopkins Verbal Learning Test-Revised for a total score of the following sub-tests: 'Total recall', 'Delayed recall', 'Retention' and 'Recognition'. Higher scores indicate better performance. | Trial days 1 and 2. | |
Secondary | Safety parameter (balance disorders) for Sativex® | Bergs Balance Test is used to measure balance disorders. Balance disorders are defined as a summerated score of =45. | Trial days 1 and 2. | |
Secondary | Safety parameter (blood pressure) for Sativex® | Blood pressure is measured in millimeter of mercury (mmHg) using automatic standardized equipment. | Trial days 1 and 2. | |
Secondary | Safety parameter (heart rate) for Sativex® | Heart rate is measured in beats per minute (bpm) using automatic standardized equipment. | Trial days 1 and 2. | |
Secondary | Correlation coefficient between clearance of gentamicin and clearance determined as mGFR or eGFR | Pharmacokinetic modeling | Trial day 3. | |
Secondary | Change in plasma creatinine µmol/L between baseline and 22 hours after administration of gentamicin | Changes in kidney biomarkeres before and after administration of gentamicin | Trial day 3 | |
Secondary | Change in plasma cystatin C mg/L between baseline and 22 hours after administration of gentamicin | Changes in kidney biomarkers before and after administration of gentamicin | Trial day 3 | |
Secondary | Change in plasma NGAL ng/mL between baseline and 22 hours after administration of gentamicin | Changes in kidney biomarkers before and after administration of gentamicin | Trial day 3 | |
Secondary | Change in plasma KIM-1 pg/mL between baseline and 22 hours after administration of gentamicin | Changes in kidney biomarkers before and after administration of gentamicin | Trial day 3 |
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