Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ended
Participants planned
130
Countries
1
Sites
1
Hip fractures
To investigate the analgesic effect of a single dose of methadone compared with a placebo in acute hip fracture surgery.
Key facts
- Sponsor
- Sygehus Soenderjylland Soenderborg
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 7 Nov 2023 → 21 Feb 2025
- Decision date (initial)
- 2023-10-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506252-24-00
- WHO UTN
- U1111-1294-6125
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To investigate the analgesic effect of a single dose of methadone compared with a placebo in acute hip fracture surgery.
Secondary objectives 1
- To investigate the long-term effects of methadone on continued opioid consumption, pain, and mobility three months after surgery.
Conditions and MedDRA coding
Hip fractures
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10053653 | Femur fracture subtrochanteric | 10022117 |
| 20.0 | LLT | 10017216 | Fracture of subtrochanteric section of femur closed | 10022117 |
| 20.0 | LLT | 10017096 | Fracture of base of neck of femur closed | 10022117 |
| 20.0 | LLT | 10017163 | Fracture of neck of femur | 10022117 |
| 20.1 | LLT | 10017236 | Fracture of unspecified part of neck of femur closed | 10022117 |
| 20.0 | LLT | 10017228 | Fracture of unspecified intracapsular section of neck of femur closed | 10022117 |
| 20.1 | LLT | 10034736 | Pertrochanteric fracture of femur closed | 10022117 |
| 20.0 | LLT | 10017159 | Fracture of midcervical section of femur closed | 10022117 |
| 20.0 | LLT | 10017130 | Fracture of intertrochanteric section of femur closed | 10022117 |
| 20.0 | LLT | 10017250 | Fracture of unspecified trochanteric section of femur closed | 10022117 |
| 20.1 | LLT | 10017299 | Fractured neck of femur | 10022117 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patients diagnosed with an acute hip fracture (incurred <24 hours ago) on x-rays in the emergency department. This includes collum femoris fractures, pertrochanteric fractures, and subtrochanteric fractures.
- Age ≥ 60 years.
Exclusion criteria 8
- Multiple fractures.
- Previous allergic reactions or hypersensitivity towards methadone hydrochloride or sodium chloride.
- Health conditions preventing treatment: • Chronic obstructive pulmonary disease with either past exacerbations or daily symptoms • History of acute asthma attacks • History of drug-induced eczema • Pulmonary hypertension • Raised intracranial pressure or recent head injury • Pheochromocytoma • History of paralytic ileus • QT-interval prolongation on electrocardiogram (ECG) • Myasthenia gravis • Known liver disorder • Hypotension (systolic blood pressure <100 mmHg at admission).
- Concurrent administration with MAO inhibitors or within 2 weeks of suspending treatment with these medicinal products.
- Concurrent administration of benzodiazepines.
- Impaired cognitive function e.g. dementia. Patients must be able to give informed consent and be able to ask for supplementary analgesics if needed.
- Current opioid addiction or intravenous addiction.
- Multi-trauma patient
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Daily consumption of opioids
Secondary endpoints 8
- Pain
- Standing up
- Mobility
- Nausea or vomiting
- Time to discharge
- Need for an antidote
- Delirium
- Constipation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP9630106 · ATC
- Active substance
- Levomethadone Hydrochloride
- Substance synonyms
- (-)-6-DIMETHYLAMINO-4,4-DIPHENYLHEPTAN-3-ONE HYDROCHLORIDE, (-)-METHADONE HYDROCHLORIDE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 20 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N07BC02 — METHADONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Natriumklorid 9 mg/ml "Fresenius Kabi", solvens til parenteralt brug
PRD2503457 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID, SODIUM CHLORIDE (FOR PH ADJUSTMENT)
- Pharmaceutical form
- SOLVENT FOR PARENTERAL USE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 20 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 17927
- MA holder
- FRESENIUS KABI AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sygehus Soenderjylland Soenderborg
- Sponsor organisation
- Sygehus Soenderjylland Soenderborg
- Address
- Kresten Philipsens Vej 15
- City
- Aabenraa
- Postcode
- 6200
- Country
- Denmark
Scientific contact point
- Organisation
- Sygehus Soenderjylland Soenderborg
- Contact name
- Department of orthopedics
Public contact point
- Organisation
- Sygehus Soenderjylland Soenderborg
- Contact name
- Department of orthopedics
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 130 | 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 |
|---|---|---|---|---|---|
| Denmark | 2023-11-07 | 2025-02-21 | 2023-11-09 | 2024-10-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results SUM-96245
|
2025-09-02T21:51:42 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary of results | 2025-09-02T21:51:47 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay_Summary_English_MetaHip | 1 |
| Summary of results (for publication) | Summary_of_Results_MetaHip | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-10 | Denmark | Acceptable 2023-09-18
|
2023-10-02 |