Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ended
Participants planned
134
Countries
1
Sites
3
hemorrhoidal disease
Compare pain at H6 post-op.
Key facts
- Sponsor
- Centre Hospitalier Departemental Vendee
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 10 Jan 2023 → 15 Jan 2026
- Decision date (initial)
- 2024-05-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514117-35-00
- EudraCT number
- 2021-006904-34
- ClinicalTrials.gov
- NCT05519189
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Compare pain at H6 post-op.
Conditions and MedDRA coding
hemorrhoidal disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patients over 18
- Patients scheduled for thermodestructive hemorrhoidal surgery (RAFAELO® procedure)
- Patient able to understand the protocol and having given written informed consent to participate in the study
- Patient affiliated to the social security system or entitled beneficiary
Exclusion criteria 8
- Patient < 18 years
- Previous hemorrhoidectomy surgery (LONGO technique)
- Patient with previous pexy ligation procedure (HAL-RAR technique)
- Patients with known hypersensitivity to local anaesthetics or their ingredients
- Patient on long-term (>1 month) analgesic treatment (Level II and III)
- Patient participating in another interventional clinical research protocol involving a drug or a clinical investigation of a medical device
- Pregnant, breast-feeding or childbearing patient without contraception
- Patient under guardianship or deprived of liberty
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Visual analogue scale (VAS) at H6 post-op (6 hours after the start of the procedure). The H6 criterion was retained, since the duration of efficacy of ropivacaine is 6 to 12 hours. It seemed appropriate to compare the 2 groups in terms of infiltration efficacy, in order to assess whether infiltration was beneficial or not.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP1158642 · ATC
- Active substance
- Ropivacaine Hydrochloride
- Route of administration
- INJECTION
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SUB10382MIG · Substance
- Active substance
- Ropivacaine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 10 mg/ml milligram(s)/millilitre
- Max total dose
- 10 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Departemental Vendee
- Sponsor organisation
- Centre Hospitalier Departemental Vendee
- Address
- Boulevard Stephane Moreau
- City
- La Roche Sur Yon Cedex 9
- Postcode
- 85925
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Departemental Vendee
- Contact name
- Chloé MOREAU
Public contact point
- Organisation
- Centre Hospitalier Departemental Vendee
- Contact name
- Chloé MOREAU
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 134 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Digestive surgery, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Saint Nazaire
Digestive surgery, 11 Boulevard Georges Charpak, Bp 414, Saint Nazaire Cedex
Centre Hospitalier Departemental Vendee
Digestive surgery, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
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 | 2023-01-10 | 2026-01-15 | 2023-01-10 |
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) | Diary_CLEAN | 2.0 |
| Protocol (for publication) | diary_TC | 2.0 |
| Protocol (for publication) | Protocol | 6.0 |
| Recruitment arrangements (for publication) | document additionnel | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements_V1_20240425 | 1 |
| Subject information and informed consent form (for publication) | Consent form | 3.0 |
| Subject information and informed consent form (for publication) | Subject information | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-514117-35-00_TABLEAU DIFF NSM-2_20250708_RAFAELOCAL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-514117-35-00_TABLEAU DIFF NSM-2_20250708_RAFAELOCAL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC | 3.0 |
| Synopsis of the protocol (for publication) | Protocol Synopsis | 3.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-29 | France | Acceptable 2024-05-27
|
2024-05-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-10 | France | Acceptable 2024-07-04
|
2024-07-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-23 | France | Acceptable 2024-07-04
|
2024-08-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-04 | France | Acceptable 2024-10-09
|
2024-10-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-15 | France | Acceptable | 2024-12-31 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-07 | France | Acceptable 2025-01-09
|
2025-01-09 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-08 | France | Acceptable 2025-01-09
|
2025-07-08 |