Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
220
Countries
1
Sites
1
Patient requiring shoulder arthroscopy
Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).
Key facts
- Sponsor
- Aquitaine Sante
- 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], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 7 Jan 2025 → 25 Jul 2025
- Decision date (initial)
- 2025-01-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Aquitaine Santé (Polyclinique Jean Villar) · Elsan
External identifiers
- EU CT number
- 2024-518947-40-01
- EudraCT number
- 2021-005710-34
- ClinicalTrials.gov
- NCT05302986
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).
Secondary objectives 4
- Evaluation of postoperative shoulder pain between the two groups
- Evaluation of patient satisfaction between the two groups
- Assessment of shoulder functionality between the two groups
- Evaluation of the safety of the treatments under study between the two groups
Conditions and MedDRA coding
Patient requiring shoulder arthroscopy
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518947-40-00 | Benefits on Post-operative Pain of Intravenous, Intraoperative, Tranexamic Acid Injection During Arthroscopic Shoulder Surgery. | Aquitaine Sante |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Male or female aged 18 years old or more
- Patient requiring shoulder arthroscopy
- Patient affiliated to a social security scheme
- Patient informed on the study and who has signed the informed consent form
Exclusion criteria 4
- Tranexamic acid contraindications (Hypersensitivity to the active substance or to any of the excipients, Acute venous or arterial thrombosis, Severe renal impairment, History of convulsions)
- Pregnant or breastfeeding patient
- Patient under legal protection
- Patient taking part simultaneously to another clinical trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Evaluation of the use of morphine treatments in the 24 postoperative hours (yes/no).
Secondary endpoints 4
- Shoulder pain is assessed through a Visual Analog Scale (0-100) performed 24 hours post-operative and 7 days after surgery (online assessment with the help of software)
- Satisfaction will be assessed through an Evaluation of the Experience of General Anesthesia questionnaire.
- The functionality of the shoulder will be evaluated at 30 days by the Subjective Shoulder Value scale and and Constant Score.
- Collection of adverse events throughout the duration of the study.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
EXACYL 0,5 g/5 ml I.V., solution injectable
PRD8535042 · Product
- Active substance
- Tranexamic Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.1 millilitre(s)/kilogram
- Max total dose
- 0.1 millilitre(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02AA02 — TRANEXAMIC ACID
- Marketing authorisation
- 34009 311 576 1 8
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
CHLORURE DE SODIUM 0,9 % BAXTER, solution pour perfusion en poche
PRD367015 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.1 millilitre(s)/kilogram
- Max total dose
- 0.1 millilitre(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 34009 351 879 5 6
- MA holder
- BAXTER SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aquitaine Sante
- Sponsor organisation
- Aquitaine Sante
- Address
- Avenue Maryse Bastie
- City
- Bruges
- Postcode
- 33520
- Country
- France
Scientific contact point
- Organisation
- Aquitaine Sante
- Contact name
- Hugues DEMEZON
Public contact point
- Organisation
- Aquitaine Sante
- Contact name
- Hugues DEMEZON
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Clinique Saint Augustin ORG-100052548
|
Bordeaux, France | Code 12, Code 5 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 220 | 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 |
|---|---|---|---|---|---|
| France | 2025-01-07 | 2025-07-25 | 2025-01-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2021-005710-34 | 3.0 |
| Protocol (for publication) | D1_Protocol_2024-518947-40-00_v4_20250114_Clean | 4.0 |
| Protocol (for publication) | D1_Protocol_2024-518947-40-00_v4_20250114_TC | 4.0 |
| Protocol (for publication) | D4_Patient facing documents_2021-005710-34 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_PROCEDURE CONSENTEMENT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_2024-518947-40-00_v4_20250114_Clean | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_2024-518947-40-00_v4_20250114_TC | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Francais 2024-518947-40-00_v4_20250114_Clean | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Francais 2024-518947-40-00_v4_20250114_TC | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2021-005710-34 | 3.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-26 | France | Acceptable 2024-12-03
|
2025-01-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-29 | France | Acceptable 2025-02-19
|
2025-03-04 |