Terminal agitation in the final phase
Conditions
Interventions
Product Name: Midazolam Nasenspray 25 mg/ml
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: MIDAZOLAM HYDROCHLORIDE
CAS Number: 59467-96-8
Concentration unit: mg/ml milligram(s)/millil
Sponsors
Universität Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patient in a palliative stage of disease. -Age = 18 years -Personal information of the patient or, in the case of patients not capable of giving consent, information of the legal representative by one of the investigators. -Ability of the participant or legal representative to understand the nature and scope of the clinical trial -Written informed consent of the patient -Diagnosis final phase -Diagnosis of terminal agitation -RASS-PAL Score > 0 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: -Conditions that interfere with nasal absorption -Hypersensitivity to midazolam or to any other component/excipient of the study medication -Parallel use of strong CYP 3A4 inducers or CYP 3A4 inhibitors -Other causes are responsible for the observed agitation symptomatology and can be treated causally -Non-drug therapy is effective and leads to improvement of the restlessness symptoms -Pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of midazolam after intranasal application in palliative patients with terminal agitation. To determine whether intranasal application of midazolam reduces the symptomatology of terminal agitation.;Secondary Objective: -To demonstrate the efficacy of midazolam after subcutaneous application in palliative patients with terminal agitation. To determine whether standard therapy as recommended by the S3 guideline Palliative Care for Patients with Noncurable Cancer, by subcutaneous application of midazolam reduces the symptomatology of terminal agitation. -Therapeutic effect levels in a concentration range c = 30 ng/ml after intranasal and after subcutaneous application of midazolam. To determine that twenty minutes after the first midazolam application, therapeutic drug levels in a concentration range c = 30 ng/ml are achieved, independent of the mode of administration (i. n. or s. c.). -Five minutes after intranasal application, higher or at least the same effect levels as after subcutaneous application. To determine whether midazolam flushes faster or at least as fast after intranasal application as after subcutaneous injection. ;Primary end point(s): Improvement in RASS-PAL score by at least one point between two observation time points after i. n. application.;Timepoint(s) of evaluation of this end point: Visit 3-5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Improvement in RASS-PAL score by at least one point between two observation time points after s. c. application. -Detection of a midazolam drug concentration in blood of c = 30 ng/ml after t3=20 min. -Quantitative analysis of blood samples at t2=5 min after drug application.;Timepoint(s) of evaluation of this end point: -Visit 3-5 -After laboratory chemical analysis of blood samples -After laboratory chemical analysis of blood samples | — |
Countries
Germany
Contacts
Public ContactIII. Medizinische Klinik
Medizinische Fakultät Mannheim der Universität Heidelberg
Outcome results
None listed