Sativex® and Gentamicin for Optimized Pharmagological Treatment in Older Patients (CanPan)

NCT05503147 | Unknown Phase 1

• 1 other identifier: H-21044231
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malnutrition; Anorexia; Cannabis; Aging; Emergency Service, Hospital; Renal Function; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Difference in energy intake (kJ) between Sativex® and placebo

  Measured at test meal

  Trial days 1 and 2.

• 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 Outcomes (14)

• 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)

  Trial days 1 and 2.

• Difference in subjective appetite between Sativex® and placebo

  Trial days 1 and 2.

• Differences in the appetite hormones, total ghrelin and glucagon like peptide 1 (GLP-1) between Sativex® and placebo

  Trial days 1 and 2.

• Change in the intraocular pressure of the eye between Sativex® and placebo

  Trial days 1 and 2.

• Safety parameter (CNS effects) for Sativex®

  Trial days 1 and 2.

Study Arms (2)

Sativex first (blinded) (3 dose of spray)

EXPERIMENTAL

Trial day 1: Sativex (3 dose of spray x 2) Trial day 2: Placebo (3 dose of spray x 2) Trial day 3: Voluntary

Drug: Sativex

Placebo first (blinded) (3 dose of spray)

EXPERIMENTAL

Trial day 1: Placebo (3 dose of spray x 2) Trial day 2: Sativex (3 dose of spray x 2) Trial day 3: Voluntary

Drug: Sativex

Interventions

Sativex DRUG

Sativex® is administered as an oromucosal spray and consists of 2.7 mg tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD) per dosis spray (Cannabis sativa L. extract, cannabis leaf and flower). The dose (3 sprays) is administered twice, at breakfast and lunch, respectively, with approximately 4 hours between each administration.

Also known as: nabiximols

Placebo first (blinded) (3 dose of spray); Sativex first (blinded) (3 dose of spray)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ove Andersen: lead
• University Hospital Bispebjerg and Frederiksberg: collaborator
• Regionshospital Nordjylland: collaborator
• University of Copenhagen: collaborator
• Region Hovedstadens Apotek: collaborator
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (1)

Clinical Research Centre

Hvidovre, 2650, Denmark

RECRUITING

Related Publications (1)

• Nielsen RL, Bornaes O, Christensen LWS, Juul-Larsen HG, Storgaard IK, Kallemose T, Jorgensen LM, Jawad BN, Altintas I, Lund TM, Rasmussen HH, Munk T, Andersen O, Houlind MB, Andersen AL. The appetite stimulating effect and safety of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in older patients with poor appetite: A triple-blinded, randomized, placebo-controlled, cross-over trial. Clin Nutr. 2025 Apr;47:248-257. doi: 10.1016/j.clnu.2025.02.024. Epub 2025 Feb 24.

  PMID: 40069983 DERIVED

MeSH Terms

Conditions

Malnutrition; Anorexia; Marijuana Abuse; Emergencies

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Ove Andersen

  Hvidovre University Hospital

  STUDY CHAIR

• Rikke L Nielsen

  Hvidovre University Hospital

  STUDY CHAIR

Central Study Contacts

Olivia Bornæs

CONTACT

+4538623184; olivia.bornaes@regionh.dk

Morten B Houlind

CONTACT

+4538623184; morten.baltzer.houlind@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director and Head of the Department of Clinical Research

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: August 16, 2022
• Study Start: March 24, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

DK (1)