A pharmacological trial with Sativex® and gentamicin for optimized pharmacological treatment of older patients with a focus on appetite stimulation and renal risk drugs

A pharmacological trial with Sativex® and gentamicin for optimized pharmacological treatment of older patients with a focus on appetite stimulation and renal risk drugs - CanPAN

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002318-15-DK

Enrollment

Registered

2021-07-12

Start date

2021-09-15

Completion date

Unknown

Last updated

2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 20.0 Level: PT Classification code 10061273 Term: Malnutrition System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: LLT Classification code 10002646 Term: Anorexia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 23.0 Level: PT Classification code 10061428 Term: Decreased appetite System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 22.0 Level: PT Classification code 10056720

Interventions

Pharmaceutical Form: Oromucosal spray INN or Proposed INN: Dronabinol Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 69

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: 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. ;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. ;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.	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: 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. ;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. ;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.

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Secondary

Measure	Time frame
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. ;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.	—

Measure

Time frame

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. ;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.

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Countries

Denmark

Contacts

Public ContactClinical Trial Information

Copenhagen University Hospital, Amager and Hvidovre, Department of Clinical Research

rikke.lundsgaard.nielsen@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026