Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Not authorised
Participants planned
88
Countries
1
Sites
1
Adult patients with indication of arthroscopic anterior cruciate ligament reconstruction
To compare the effect of perioperative dexamethasone administration versus saline solution administration on postoperative pain after single-bundle anterior cruciate ligament reconstruction
Key facts
- Sponsor
- Ospedale San Raffaele S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2024-12-17
- 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: Efficacy, Therapy
To compare the effect of perioperative dexamethasone administration versus saline solution administration on postoperative pain after single-bundle anterior cruciate ligament reconstruction
Secondary objectives 2
- To assess the effect of perioperative dexamethasone administration on nausea, vomiting and functional recovery (stiffness reduction in patients treated with dexamethasone) after single-bundle anterior cruciate ligament reconstruction
- To determine whatever dexamethasone could be associated with an increase in surgical site infection and other complications
Conditions and MedDRA coding
Adult patients with indication of arthroscopic anterior cruciate ligament reconstruction
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10078191 | Anterior cruciate ligament reconstruction | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Participants willing and able to sign informed consent for participation in the study
- Male and female, aged between 18 and 45 years old
- Patients without comorbidities
- Ability to take oral medication during the follow up, including analgesic, antiemetics and opioids
- Females in reproductive age: GRAVINDEX (agglutination inhibition test performed on a urine sample to detect pregnancy, based on double antigen antibody reaction) will be performed before surgery to exclude eventually pregnant women. Women taking oral contraceptive or using other methods of contraception can be included.
- Males in reproductive age will be included
- Confirmed diagnosis of complete anterior cruciate ligament rupture, confirmation is achieved through clinical diagnostic tests.
- Patients undergoing single-bundle anterior cruciate ligament (ACL) reconstruction using an autograft (gracilis or semitendinosus tendon) with the ULTRABUTTON™ Adjustable Fixation technique will be included in the study
Exclusion criteria 16
- Active viral and bacterial infections
- Previous Surgery or fractures on the affected knee
- Kidney diseases (GRF < 90 ml/min)
- History of thrombosis
- Allergy or hypersensitivity to any component of the IMP (dexamethasone), including excipients
- Drug contraindication: bacterial and fungal infections, peptic ulcers, psychosis, ocular herpes simplex virus infection, local injection in infected sites, local injection in unstable joints
- Chronic steroid use
- Pregnant and/or breastfeeding women
- Ongoing immunosuppressive therapies
- Rheumatic diseases
- Peptic ulcer
- Diabetes
- Multi-ligament Injuries
- Age < 18 years and > 45 years
- Knee Osteoarthritis
- Patients with severe cartilage damage
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pain levels will be measured by VAS from participants in each treatment arm at rest and during walking
Secondary endpoints 2
- Pain levels with VAS from participants in each treatment arm at rest and during walking The number of episodes of nausea and vomiting will be recorded from participants in each treatment arm.
- Functional scores (range of movement, length of stay, and earlier return to activity of daily life evaluated in terms of walking with crutches in the days after surgery without invalidating pain) will be evaluated in patients in the control group versus study group. Number of patients who experience surgical site infection and complications (fever, wound infections, delayed tissue healing and gastrointestinal bleeding)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SOLDESAM 8 mg/2 ml soluzione iniettabile
PRD354313 · Product
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 2 ml millilitre(s)
- Max total dose
- 2 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 019499084
- MA holder
- LABORATORIO FARMACOLOGICO MILANESE S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SODIO CLORURO 0,9% BAXTER Soluzione per infusione
PRD367519 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 4 mg/ml milligram(s)/millilitre
- Max total dose
- 4 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 035715022
- MA holder
- BAXTER S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ospedale San Raffaele S.r.l.
- Sponsor organisation
- Ospedale San Raffaele S.r.l.
- Address
- Via Olgettina 60
- City
- Milan
- Postcode
- 20132
- Country
- Italy
Scientific contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Alessio Mattia Mazzola
Public contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Alessio Mattia Mazzola
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Not authorised | 88 | 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 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2024-511559-17-00_Redacted | 1.2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Redacted | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ RCP dexamethasone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC dexamethasone | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_EN 2024-511559-17-00_Redacted | 1.2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_IT 2024-511559-17-00_Redacted | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-11 | Italy | Not acceptable 2024-12-16
|
2024-12-17 |