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

NCT05503147 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-09-21

No results posted yet for this study

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

Interventions

DRUG

Sativex

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.

Sponsors & Collaborators

  • University Hospital Bispebjerg and Frederiksberg

    collaborator OTHER

  • Regionshospital Nordjylland

    collaborator OTHER_GOV

  • University of Copenhagen

    collaborator OTHER

  • Region Hovedstadens Apotek

    collaborator OTHER_GOV

  • Glostrup University Hospital, Copenhagen

    collaborator OTHER

  • Ove Andersen

    lead OTHER

Principal Investigators

  • Ove Andersen · Hvidovre University Hospital

  • Rikke L Nielsen · Hvidovre University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2023-08-01
Completion
2023-09-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05503147 on ClinicalTrials.gov