Overview
Sponsor-declared trial summary
chronic common low back pain
Evaluate the benefit of Localized Tissue Hydration (LTH) associated with standard management of chronic common low back pain, in terms of improvement in the Verbal Numerical Scale (VNS) score at 6 months
Key facts
- Sponsor
- Groupement De Cooperation Sanitaire Ramsay Generale De Sante Pour L'enseignement Et La Recherche
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 14 Nov 2024 → 31 Mar 2026
- Decision date (initial)
- 2024-05-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
Evaluate the benefit of Localized Tissue Hydration (LTH) associated with standard management of chronic common low back pain, in terms of improvement in the Verbal Numerical Scale (VNS) score at 6 months
Conditions and MedDRA coding
chronic common low back pain
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patient aged 18 or over
- Patient suffering from not operated chronic common low back pain going on since more than 3 months (VNS ≥ 5)
- Chronic common low back pain not requiring surgical care
- Lumbar MRI performed as part of routine care available for the inclusion visit
- Patient affiliated to one National Health Insurance scheme
- Patient having signed informed consent
Exclusion criteria 7
- Pregnant or breastfeeding woman
- Patient in work accident
- Patient with radicular syndrome
- Contraindication to performing an MRI or CT scan
- Patient hospitalized without consent
- atient unable to answer a questionnaire; Patient not understanding or speaking French
- Adult patient subject to a legal protection measure, curatorial guardianship or deprived of liberty by a judicial or administrative decision
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Success rate after Localized Tissue Hydration (LHT) treatment combined with standard care, defined by a reduction in the EVN score of at least 30% between M0 and M6. The EVN is a scale ranging from 0 to 10. It will be completed at the inclusion visit (M0) and at the follow-up visits after the end of treatment (M3 and M6). The primary endpoint will be collected at the M6 follow-up visit.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
CHLORURE DE SODIUM FRESENIUS 0,9 %, solution pour perfusion
PRD2503487 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 0.5 l litre(s)
- Max total dose
- 5 l litre(s)
- Max treatment duration
- 10 Week(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 34009 367 514 1 5
- MA holder
- FRESENIUS KABI FRANCE S.A.S.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Nouvelle indication thérapeutique : prise en charge de la lombalgie commune chronique (définie par une douleur lombaire depuis plus de 3 mois, non opérée et ne nécessitant pas une prise en charge chirurgicale); modification du mode d'administration
CHLORURE DE SODIUM FRESENIUS 0,9 %, solution pour perfusion
PRD2503486 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 0.5 l litre(s)
- Max total dose
- 5 l litre(s)
- Max treatment duration
- 10 Week(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 34009 367 513 5 4
- MA holder
- FRESENIUS KABI FRANCE S.A.S.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Nouvelle indication thérapeutique : prise en charge de la lombalgie commune chronique (définie par une douleur lombaire depuis plus de 3 mois, non opérée et ne nécessitant pas une prise en charge chirurgicale); modification du mode d'administration
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Groupement De Cooperation Sanitaire Ramsay Generale De Sante Pour L'enseignement Et La Recherche
- Sponsor organisation
- Groupement De Cooperation Sanitaire Ramsay Generale De Sante Pour L'enseignement Et La Recherche
- Address
- 39 Rue Mstislav Rostropovitch
- City
- Paris
- Postcode
- 75017
- Country
- France
Scientific contact point
- Organisation
- Groupement De Cooperation Sanitaire Ramsay Generale De Sante Pour L'enseignement Et La Recherche
- Contact name
- neurosurgeon
Public contact point
- Organisation
- Groupement De Cooperation Sanitaire Ramsay Generale De Sante Pour L'enseignement Et La Recherche
- Contact name
- neurosurgeon
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 29 | 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 | 2024-11-14 | 2026-03-31 | 2025-02-28 | 2025-07-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PROTOCOL_2024-510625-25-00 | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_NIFC_2024-510625-25-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_RCP Chlorure de sodium_injection | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_RCP_Chlorure de sodium_perfusion | 1 |
| Synopsis of the protocol (for publication) | D1_PROTOCOL_SYNOPSIS_2024-510625-25-00 | 3 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-13 | France | Acceptable 2024-05-24
|
2024-05-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-04 | France | Acceptable 2024-05-24
|
2024-07-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-29 | France | Acceptable | 2025-02-28 |