Overview
Sponsor-declared trial summary
Symptom treatment in the last days of life of geriatric patients
1. To characterize the relationship between morphine dosing and the time to symptom control (discomfort/pain and dyspnea) in geriatric patients during their last days of life. 2. To characterize the relationship between midazolam dosing and the time to symptom control (discomfort/pain, dyspnea and agitation) in geriatr…
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 3 Feb 2025 → 31 Dec 2025
- Decision date (initial)
- 2025-01-20
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Pharmacokinetic, Safety, Dose response
1. To characterize the relationship between morphine dosing and the time to symptom control (discomfort/pain and dyspnea) in geriatric patients during their last days of life.
2. To characterize the relationship between midazolam dosing and the time to symptom control (discomfort/pain, dyspnea and agitation) in geriatric patients during their last days of life.
3. To characterize the relationship between morphine dosage and the occurrence of adverse drug reactions in geriatric patients during their last days of life.
4. To characterize the relationship between midazolam dosage and the occurrence of adverse drug reactions in geriatric patients during their last days of life.
Secondary objectives 6
- 5. What factors influence morphine pharmacokinetics in geriatric patients during their last days of life?
- 6. What factors influence morphine pharmacodynamics in geriatric patients during their last days of life?
- 7. What factors influence midazolam pharmacokinetics in geriatric patients during their last days of life?
- 8. What factors influence midazolam pharmacodynamics in geriatric patients during their last days of life?
- 9. To characterize the relationship between morphine and midazolam dosages and the time until death after establishment of the dying phase?
- 10. How do creatinine, urea, albumin, bilirubin, GGT, ALT, sodium, CRP and urinary creatinine evolve in geriatric patients during their last days of life?
Conditions and MedDRA coding
Symptom treatment in the last days of life of geriatric patients
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Hospitalization on the acute geriatric ward
- Patient expected to die in the following hours or days
Exclusion criteria 1
- Expected discharge from the hospital before death
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Morphine and midazolam doses, time of administration and route of administration
- Symptom control: discomfort scale, agitation/sedation scale and dyspnea scale
- Adverse reactions: : nausea, vomiting, hallucinations, constipation, myoclonus, pruritus, hiccups, respiratory rate and other adverse reactions occurring that are related to the Morphine and Midazolam injection according to the nurse or doctor.
Secondary endpoints 3
- Morphine, morphine-3-glucuronide and morphine-6-glucuronide plasma concentrations
- Midazolam and alpha-hydroxy-midazolam glucuronide plasma concentrations
- Blood creatinine, urea, albumin, bilirubin, GGT, ALT, sodium, CRP and urinary creatinine concentrations
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP112629113 · ATC
- Active substance
- Dobutamine Hydrochloride
- Route of administration
- INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 4200 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05CD08 — MIDAZOLAM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1000773 · ATC
- Active substance
- Morphine
- Route of administration
- INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 4200 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Leuven
- Sponsor organisation
- UZ Leuven
- Address
- Herestraat 49
- City
- Leuven
- Postcode
- 3000
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Leuven
- Contact name
- Tim Biesbrouck
Public contact point
- Organisation
- UZ Leuven
- Contact name
- Tim Biesbrouck
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 300 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-02-03 | 2025-12-31 | 2025-02-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-517763-22 | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | Informed consent procedure | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient observational | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient PK sub-study dutch | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF relative observational | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF relative PK sub-study dutch | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Midazolam | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Midazolam | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Morphine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Morphine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Morphine | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DU 2024-517763-22 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2024-517763-22 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2024-517763-22 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL 2024-517763-22 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-24 | Belgium | Acceptable with conditions 2025-01-15
|
2025-01-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-13 | Belgium | Acceptable 2026-01-29
|
2026-01-29 |