Clinical trial • Phase III • Musculoskeletal
L-ASCORBIC ACID for Complex regional pain syndrome (CRPS) type 1 | Algoneurodystrophy
Phase III trial of L-ASCORBIC ACID for Complex regional pain syndrome (CRPS) type 1 | Algoneurodystrophy.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Complex regional pain syndrome (CRPS) type 1 | Algoneurodystrophy
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Other
Key dates
- Initial CTIS Submission Date
- 23-09-2024
- First CTIS Authorization Date
- 10-10-2024
Trial design
Randomised, placebo comparator: cellulose, microcrystalline (placebo) oral powder; test product: l-ascorbic acid (vitamin c) capsule, oral. dose-related fields: product entries list max daily dose 500 mg; specific starting dose and schedule not specified in the ctis record.-controlled Phase III trial across 2 sites in France.
- Randomised
- Yes
- Comparator
- Placebo comparator: CELLULOSE, MICROCRYSTALLINE (Placebo) oral powder; Test product: L-ASCORBIC ACID (vitamin C) capsule, oral. Dose-related fields: product entries list max daily dose 500 mg; specific starting dose and schedule not specified in the CTIS record.
- Target Sample Size
- 1000
- Trial Duration For Participant
- 365
Eligibility
Recruits 1000 Vulnerable populations: children are excluded ('children'); patients under guardianship are excluded ('patients under guardianship'). Consent: participants must be able to give consent ('patients able to give their consent to follow the protocol of treatment and monitoring'). A Subject Information Sheet and Informed Consent Form is available (document: 'L1_SIS and ICF patient', version 1.3)..
- Pregnancy Exclusion
- Woman of childbearing potential without an effective contraceptive method; pregnant or lactating women
- Vulnerable Population
- Vulnerable populations: children are excluded ('children'); patients under guardianship are excluded ('patients under guardianship'). Consent: participants must be able to give consent ('patients able to give their consent to follow the protocol of treatment and monitoring'). A Subject Information Sheet and Informed Consent Form is available (document: 'L1_SIS and ICF patient', version 1.3).
Inclusion criteria
- {"criterion_text":"-patients over 18 yo undergoing major surgery of the upper limb"}
- {"criterion_text":"-patients able to give their consent to follow the protocol of treatment and monitoring"}
- {"criterion_text":"-Patient with social security coverage"}
Exclusion criteria
- {"criterion_text":"-Patient not wishing to be part of the study, or out of condition to express consent"}
- {"criterion_text":"-patients suffering or having already suffered from complex regional pain syndrome type 1 or type 2"}
- {"criterion_text":"-Patient seeking follow-up outside referral centres"}
- {"criterion_text":"-patients unable due to personal or professional mobility, to conduct post-operative follow up"}
- {"criterion_text":"-patients undergoing surgery with nerve suture with nerve graft"}
- {"criterion_text":"-Patient requiring two surgical procedures on the same limb"}
- {"criterion_text":"-emergency surgery"}
- {"criterion_text":"-children"}
- {"criterion_text":"-patients under guardianship"}
- {"criterion_text":"-Woman of childbearing potential without an effective contraceptive method"}
- {"criterion_text":"-pregnant or lactating women"}
- {"criterion_text":"-patients with hemochromatosis"}
- {"criterion_text":"-patients with chronic kidney disease"}
- {"criterion_text":"-patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency"}
- {"criterion_text":"-allergy or known hypersensitivity to one of the molecules of treatment"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Appearance of a complex regional pain syndrome (CRPS) 6 months after surgery","definition_or_measurement_approach":"Presence or absence of CRPS type 1 at 6 months after surgery (diagnosis of CRPS type 1 assessed per the study diagnostic criteria as described in the protocol)."}
Secondary endpoints
- {"endpoint_text":"-Epidemiological description of CRPS affected population","definition_or_measurement_approach":"Descriptive analysis (overall and per arm) of the population affected by CRPS Type 1: age, sex, history, type of surgery; based on data collected from included patients."}
- {"endpoint_text":"-Appearance of a complex regional pain syndrome (CRPS) 12 months after surgery","definition_or_measurement_approach":"Presence or absence of CRPS type 1 at 12 months after surgery, assessed according to the same diagnostic criteria described for the 6-month endpoint."}
- {"endpoint_text":"-C Vitamin tolerance and protocol compliance","definition_or_measurement_approach":"Evaluation of tolerance and adherence to vitamin C by collecting tolerance data at the day of the intervention and at post-operative consultations (6 and 12 months); assessment via patient interview and follow-up visits."}
Recruitment
- Planned Sample Size
- 1000
- Recruitment Window Months
- 114
- Consent Approach
- Informed consent must be provided by the participant (adult). Children are excluded. A Subject Information Sheet and Informed Consent Form is available ('L1_SIS and ICF patient', version 1.3). Consent language: French (translations and protocol materials include French).
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 1000
France
- Earliest CTIS Part Ii Submission Date
- 01-10-2024
- Latest Decision Or Authorization Date
- 10-10-2024
- Processing Time Days
- 9
- Number Of Sites
- 2
- Number Of Participants
- 1000
Sites
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Orthopédie et Traumatologie
- Principal Investigator Name
- Emmanuel DAVID
- Principal Investigator Email
- David.Emmanuel@chu-amiens.fr
- Contact Person Name
- Emmanuel DAVID
- Contact Person Email
- David.Emmanuel@chu-amiens.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Chirurgie plastique et de la main
- Principal Investigator Name
- Isabelle AUQUIT-AUCKBUR
- Principal Investigator Email
- Isabelle.auquit-auckbur@chu-rouen.fr
- Contact Person Name
- Isabelle AUQUIT-AUCKBUR
- Contact Person Email
- Isabelle.auquit-auckbur@chu-rouen.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire Amiens Picardie
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- L-ASCORBIC ACID
- Active Substance
- L-ASCORBIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- No marketing authorization (marketingAuthNumber: '-')
- Maximum Dose
- 500 mg (max daily as listed)
- Investigational Product Name
- CELLULOSE, MICROCRYSTALLINE
- Active Substance
- CELLULOSE, MICROCRYSTALLINE
- Modality
- Other
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- No marketing authorization (marketingAuthNumber: '-')
- Maximum Dose
- 500 mg (max daily as listed)
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