Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
80
Countries
1
Sites
1
Orthopedic surgery
Determine the effects of methadone on analgesic requirements and pain scales in the first 24 hours after orthopedic surgery without locoregional anesthesia, compared to patients receiving standard doses of sufentanil.
Key facts
- Sponsor
- Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 1 Mar 2023 → ongoing
- Decision date (initial)
- 2024-12-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- CHU Brugmann
External identifiers
- EU CT number
- 2024-518059-50-00
- EudraCT number
- 2023-000172-36
- ClinicalTrials.gov
- NCT05831345
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Determine the effects of methadone on analgesic requirements and pain scales in the first 24 hours after orthopedic surgery without locoregional anesthesia, compared to patients receiving standard doses of sufentanil.
Secondary objectives 1
- The secondary objective is greater satisfaction of patients receiving methadone in their pain management in the three postoperative days, compared to those receiving sufentanil, without an increase in complications and side effects
Conditions and MedDRA coding
Orthopedic surgery
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | LLT | 10051079 | Orthopedic procedure | 10042613 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Entire trial Entire clinical trial
|
Randomised Controlled | Double | [{"id":159172,"code":1,"name":"Subject"},{"id":159173,"code":2,"name":"Investigator"}] | Methadone: IMP is Methadone sufentanil: IMP is sufentanil |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age between 18 and 80 years old
- ASA 1-3 status
- Elective partial or total hip and knee arthroplasty
Exclusion criteria 9
- Preoperative renal failure (serum creatinine > 2 mg/dL or 1.5-fold increase in basal plasma creatinine or GFR < 50 ml/min/1.73m2)
- Significant hepatic dysfunction (PT <50% or increase in 3 times basal transaminases)
- Known heart failure
- Preoperative hemodynamic instability (preoperative use of inotropes or vasopressors)
- Known methadone or sufentanil allergy
- Preoperative opioid use or history of opioid abuse
- Pregnancy and breastfeeding
- Treatment with beta blockers and HR < 60 bpm
- Treatment with antidepressants
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Postoperative pain will be assessed by nurses in the recovery room and inpatient unit: total morphine consumption is noted and postoperative pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 to 10) at rest and during coughing at 11 different intervals. The level of sedation is also measured using a 5-point scale (Rudkin scale) and episodes of nausea and vomiting, side effects and complications are also encoded.
Secondary endpoints 1
- The pain is then evaluated during the three postoperative days thanks to the EVA but also via a general satisfaction questionnaire concerning the management of pain at the end of the stay. Side effects and complications are encoded.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
MEPHENON 10mg/1ml solution injectable
PRD7571563 · Product
- Active substance
- Methadone Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N07BC02 — METHADONE
- Marketing authorisation
- BE117327
- MA holder
- LABORATOIRES STEROP
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
PRD6948320 · Product
- Active substance
- Sufentanil
- Substance synonyms
- OX27
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 20 µg microgram(s)
- Max total dose
- 20 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH03 — SUFENTANIL
- Marketing authorisation
- 13895
- MA holder
- PIRAMAL CRITICAL CARE B.V.
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
- Sponsor organisation
- Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
- Address
- Arthur Van Gehuchtenplein 4
- City
- Brussels
- Postcode
- 1020
- Country
- Belgium
Scientific contact point
- Organisation
- Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
- Contact name
- Anesthesiology Department
Public contact point
- Organisation
- Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
- Contact name
- Anesthesiology Department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 80 | 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 | 2023-03-01 | 2023-08-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518059-50-00 redacted | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements -CTD | 1 |
| Subject information and informed consent form (for publication) | L1_ICF FR | 1.5 |
| Subject information and informed consent form (for publication) | L1_ICF NL | 1.5 |
| Subject information and informed consent form (for publication) | L1_SIS FR redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1_SIS NL redacted | 1.5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mephenon | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Sufenta | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR 2024-518059-50-00 | 5 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-29 | Belgium | Acceptable 2024-12-09
|
2024-12-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-26 | Belgium | Acceptable 2024-12-09
|
2025-11-26 |