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

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10061273Term: MalnutritionSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: LLTClassification code 10002646Term: AnorexiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 23.0Level: PTClassification code 10061428Term: Decreased appetiteSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 22.0Level: PTClassification code 10056720Term: Muscle massSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 21.0Level: LLTClassification code 10053349Term: Pharmacokinetic studySystem Organ Class: 10022891 - Investigations; MedDRA version: 21.1Level: PTClassification code 10018355Term: Glomerular filtration rateSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2021-002318-15-DK
• Lead Sponsor: Copenhagen University Hospital, Amager and Hvidovre, Department of Clinical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-12
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 69

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified