Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
60
Countries
1
Sites
1
chronic idiopathic ano-perineal pain
evaluate the efficacy of posterior perineal block performed under neurostimulation on pain 1 month after local anesthetic infiltration in the treatment of chronic idiopathic ano-perineal pain.
Key facts
- Sponsor
- Groupe Hospitalier Diaconesses Croix Saint Simon
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2024-12-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518148-19-00
- EudraCT number
- 2021-001494-23
- WHO UTN
- U2021-0014-9423
- ClinicalTrials.gov
- NCT06602349
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
evaluate the efficacy of posterior perineal block performed under neurostimulation on pain 1 month after local anesthetic infiltration in the treatment of chronic idiopathic ano-perineal pain.
Secondary objectives 5
- The rate of maintenance at 3 months of a positive response to the first infiltration
- The pain-free rate at 1 month after the first infiltration
- Evolution of quality of life and pain impact between inclusion and one month after the first infiltration
- Changes in anxiety and depressive disorders associated with pain between inclusion and one month after the first infiltration
- The evolution of symptoms related to central sensitization (both somatic and emotional) between inclusion and one month after the first infiltration
Conditions and MedDRA coding
chronic idiopathic ano-perineal pain
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | study design phase III, efficacity trial, double blind versus control
|
Randomised Controlled | Double | [{"id":98435,"code":3,"name":"Monitor"},{"id":98437,"code":1,"name":"Subject"},{"id":98436,"code":5,"name":"Carer"},{"id":98438,"code":2,"name":"Investigator"}] | controled: physiological serum experimental: lidocaine |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patient 18 years of age or older
- Express consent to participate in the study
- Affiliated or beneficiary of a social security plan
- Presenting chronic idiopathic ano-perineal pain
- Normal MRI or no pathology explaining pain
- Resistance to “standard” 1st-line medical treatment (1 or 2 analgesics and/or NSAIDs and/or local topicals).
Exclusion criteria 8
- Patient under legal protection
- Pregnant or breast-feeding woman
- Current general and/or local infection (fistulous or cutaneous suppuration of anal margin)
- Known neurological pathology that may explain pain
- Psychiatric pathology requiring medication
- Anticoagulants or haemostasis disorders
- Hypersensitivity to lidocaine hydrochloride or local anesthetics
- Recurrent porphyrias
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Comparison between the two treatment arms (lidocaine versus saline) of the rate of patients with a reduction of at least 3 points on a visual analog pain scale (VAS) between inclusion and 1 month after the first injection.
Secondary endpoints 5
- Maintenance of positive response at 3 months, defined as a reduction of at least 3 VAS pain score points (compared with inclusion) 3 months after infiltration.
- Percentage of patients with a VAS score equal to 0 at 1 month after the first infiltration
- Delta of the score on question 9 of the "modified" Concise Pain Questionnaire (CPQ) (French version of the Brief Pain Inventory) concerning the impact of pain
- Delta of scores A (anxiety dimension) and D (depression dimension) on the HAD scale
- Delta of the score for part A of the French version of the CSI central sensitization score
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
LIDOCAINE AGUETTANT 10 mg/mL SANS CONSERVATEUR, Solution injectable
PRD5551339 · Product
- Active substance
- Lidocaine Hydrochloride Monohydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 180 mg milligram(s)
- Max total dose
- 180 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB02 — LIDOCAINE
- Marketing authorisation
- 34009 277 224 4 8
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
CHLORURE DE SODIUM PROAMP 0,9 %, solution injectable
PRD648168 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 18 ml millilitre(s)
- Max total dose
- 18 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 34009 366 934-7
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Groupe Hospitalier Diaconesses Croix Saint Simon
- Sponsor organisation
- Groupe Hospitalier Diaconesses Croix Saint Simon
- Address
- 125 Rue D Avron
- City
- Paris
- Postcode
- 75020
- Country
- France
Scientific contact point
- Organisation
- Groupe Hospitalier Diaconesses Croix Saint Simon
- Contact name
- principal investigator
Public contact point
- Organisation
- Groupe Hospitalier Diaconesses Croix Saint Simon
- Contact name
- principal investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 60 | 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 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2021-001494-23_PROTOCOLE_EPHI-DACI | 3.0 |
| Recruitment arrangements (for publication) | 2021-001494-Recruitement_and_inform_consent_EPHI-DACI | 1 |
| Subject information and informed consent form (for publication) | 2021-001494-23_NIFC_EPHI-DACI | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP LIDOCAINE | 1 |
| Synopsis of the protocol (for publication) | 2021-001494-23_resume_EPHI-DACI | 3.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-25 | France | Acceptable 2024-12-10
|
2024-12-11 |