Overview
Sponsor-declared trial summary
Patients aged 60 years or older undergoing total hip arthroplasty
To evaluate the effect of different doses of a single intraoperative dose of dexamethasone (5 mg versus 25 mg) on health-related quality of life up to three months after surgery
Key facts
- Sponsor
- Ziekenhuis Oost Limburg
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 30 Jan 2026 → ongoing
- Decision date (initial)
- 2026-01-21
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the effect of different doses of a single intraoperative dose of dexamethasone (5 mg versus 25 mg) on health-related quality of life up to three months after surgery
Conditions and MedDRA coding
Patients aged 60 years or older undergoing total hip arthroplasty
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- aged 60 years or older
- scheduled for elective total hip arthroplasty
- procedure under spinal anaesthesia
Exclusion criteria 5
- hip revision surgery (reoperation)
- bilateral total hip arthroplasty during the same procedure
- chronic systemic use of corticosteroids, defined as daily corticosteroid therapy for > 4 weeks within the last 3 months, with anticipated need for a perioperative stress dose of corticosteroids
- lack of informed consent or inability to give informed consent
- urgent, non-elective surgery
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Health-related quality of life (EQ-5D-5L) on day 30, 60 and 90 following surgery
Secondary endpoints 5
- Quality of recovery (QoR-15) on day 1, day 3, and day 5 following surgery
- Health-related quality of life (EQ-VAS) on day 30, 60 and 90 following surgery
- Oxford Hip Score (OHS) on day 30, 60 and 90 following surgery
- Brief Pain Inventory (BPI) on day 30, 60 and 90 following surgery
- Chalder fatigue questionnaire (CFQ) on day 30, 60 and 90 following surgery
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Aacidexam 5 mg/ml oplossing voor injectie
PRD3570600 · Product
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- BE080026
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Aacidexam 5 mg/ml solution injectable
PRD4933050 · Product
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- BE080026
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ziekenhuis Oost Limburg
- Sponsor organisation
- Ziekenhuis Oost Limburg
- Address
- Synaps Park 1
- City
- Genk
- Postcode
- 3600
- Country
- Belgium
Scientific contact point
- Organisation
- Ziekenhuis Oost Limburg
- Contact name
- Clinical Trial Unit
Public contact point
- Organisation
- Ziekenhuis Oost Limburg
- Contact name
- Clinical Trial Unit
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 224 | 1 |
| 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 | 2026-01-30 | 2026-01-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-524368-39-00 | 1 |
| Protocol (for publication) | D1_Protocol 2025-524368-39-00 V1_1 | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF 2025-524368-39-00 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF 2025-524368-39-00 V1_1 | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Aacidexam | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Aacidexam | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis De 2025-524368-39-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis De 2025-524368-39-00 V1_1 | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Fr 2025-524368-39-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Fr 2025-524368-39-00 V1_1 | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Nl 2025-524368-39-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Nl 2025-524368-39-00 V1_1 | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-05 | Belgium | Acceptable 2026-01-21
|
2026-01-21 |