Overview
Sponsor-declared trial summary
Algoneurodystrophy CRPS type 1
The aim of the study is to demonstrate a significant reduction of CRPS 1 when taking vitamin C during the perioperative period in upper limb surgery.
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2024-10-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518310-28-00
- EudraCT number
- 2015-000145-24
- ClinicalTrials.gov
- NCT02390505
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
The aim of the study is to demonstrate a significant reduction of CRPS 1 when taking vitamin C during the perioperative period in upper limb surgery.
Secondary objectives 3
- to compare between the 2 arms the occurrence of CRPS Type 1, one year after surgery
- Descriptive analysis (overall and per arm) of the population affected by CRPS Type 1: age, sex, history, type of surgery.
- Evaluation of tolerance and attendance taking vitamin C in pre and post operative period.
Conditions and MedDRA coding
Algoneurodystrophy CRPS type 1
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- patients over 18 yo undergoing major surgery of the upper limb
- patients able to give their consent to follow the protocol of treatment and monitoring
- Patient with social security coverage
Exclusion criteria 15
- Patient not wishing to be part of the study, or out of condition to express consent
- children
- patients under guardianship
- Woman of childbearing potential without an effective contraceptive method
- pregnant or lactating women
- patients with hemochromatosis
- patients with chronic kidney disease
- patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency
- allergy or known hypersensitivity to one of the molecules of treatment
- patients suffering or having already suffered from complex regional pain syndrome type 1 or type 2
- Patient seeking follow-up outside referral centres
- patients unable due to personal or professional mobility, to conduct post-operative follow up
- patients undergoing surgery with nerve suture with nerve graft
- Patient requiring two surgical procedures on the same limb
- emergency surgery
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery
Secondary endpoints 3
- Epidemiological description of CRPS affected population
- Appearance of a complex regional pain syndrome (CRPS) 12 months after surgery
- C Vitamin tolerance and protocol compliance
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB127188 · Substance
- Active substance
- L-Ascorbic Acid
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 26 g gram(s)
- Max treatment duration
- 52 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12626MIG · Substance
- Active substance
- Cellulose, Microcrystalline
- Pharmaceutical form
- ORAL POWDER
- Route of administration
- ORAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 26 g gram(s)
- Max treatment duration
- 52 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 Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Docteur Emmanuel DAVID
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Hermil Lucile
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 1,000 | 2 |
| 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 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-518310-28-00 | 5 |
| Recruitment arrangements (for publication) | NA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-23 | France | Acceptable 2024-10-10
|
2024-10-10 |