Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
40
Countries
1
Sites
1
sickle cell anaemia
The primary outcome of this study will be a decrease in overall morphine consumption in the intervention group.
Key facts
- Sponsor
- CHU Saint Pierre
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Decision date (initial)
- 2026-01-26
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Association Vésale
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The primary outcome of this study will be a decrease in overall morphine consumption in the intervention group.
Secondary objectives 2
- Decrease in pain scores
- Decrease in morphine's secondary effects
Conditions and MedDRA coding
sickle cell anaemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10072397 | Vaso-occlusive crisis | 10005329 |
| 21.0 | PT | 10040644 | Sickle cell disease | 100000004850 |
| 20.0 | PT | 10040642 | Sickle cell anaemia with crisis | 100000004851 |
| 21.0 | PT | 10040641 | Sickle cell anaemia | 100000004850 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Two arms There will be two groups in this study, a Control group (standard of care) and an Intervention group.
|
Randomised Controlled | Double | [{"id":162333,"code":1,"name":"Subject"},{"id":162334,"code":5,"name":"Carer"},{"id":162332,"code":2,"name":"Investigator"}] | Control: Morphine PCA - Standard of care. Intervention: Morphine and Lidocaine PCA. |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-523777-41-00 | Morphine PCA vs Morphine and Lidocaine PCA for the treatment of vaso-occlusive crisis-related pain in sickle-cell anaemia patients: a prospective, randomized, double blind monocentric trial. | CHU Saint Pierre |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Vaso - occlusive crisis needing morphine PCA
- Age 18 or older
Exclusion criteria 4
- Age under 18
- Pregnancy
- Allergy or adverse reaction to morphine or lidocaine
- Patient's refusal
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Reduction in morphine consumption
Secondary endpoints 3
- Evolution of biomarkers
- Evolution of pain scores using the VAS score
- Occurence of morphine-related adverse effects
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB88133 · Substance
- Active substance
- Lidocaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 1080 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SUB14596MIG · Substance
- Active substance
- Morphine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 216 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CHU Saint Pierre
3
Total trials
Academic / Non-commercial
- Sponsor organisation
- CHU Saint Pierre
- Address
- Hoogstraat 322
- City
- Brussels
- Postcode
- 1000
- Country
- Belgium
Scientific contact point
- Organisation
- CHU Saint Pierre
- Contact name
- Andrea Carini
Public contact point
- Organisation
- CHU Saint Pierre
- Contact name
- Andrea Carini
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D Protocol 09 25 | 1.2 |
| Recruitment arrangements (for publication) | K59 recruitment procedure 09 25 | 2 |
| Subject information and informed consent form (for publication) | K 60 2 FR | 1 |
| Subject information and informed consent form (for publication) | K 60 3 FR | 1 |
| Subject information and informed consent form (for publication) | K 60 4 FR | 1 |
| Subject information and informed consent form (for publication) | K 60 ENG 09 25 pdf | 1 |
| Subject information and informed consent form (for publication) | K 60 FR 1 | 1 |
| Subject information and informed consent form (for publication) | K 60 NL 12 25 | 1 |
| Subject information and informed consent form (for publication) | K 60 template ENG pdf | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | F Lidocaine SMPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | F Morphine SMPC | 1 |
| Synopsis of the protocol (for publication) | D synopsis ENG 09 25 | 1 |
| Synopsis of the protocol (for publication) | D synopsis FR 09 25 | 1 |
| Synopsis of the protocol (for publication) | D synopsis NL 09 25 | 1 |
| Synopsis of the protocol (for publication) | D_60 synopsis DE | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-21 | Belgium | Acceptable with conditions 2026-01-26
|
2026-01-26 |