Neuropathic Pain
Conditions
Keywords
Pre-emptive administration, Post-operative administration, Prophylaxis, Memantine, Post-mastectomy/tumorectomy, Neuropathic pain
Brief summary
The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.
Detailed description
The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.
Interventions
DRUGMemantine EBIXA®
The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.
DRUGPlacebo : lactose
The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old * patient suffering breast cancer with mastectomy/tumorectomy with or within cleaning 2 weeks after inclusion with or within pre-emptive chemotherapy
Exclusion criteria
* Against-indication at memantine administration : hypersensitivity at active substance or excipients, hypertension, antecedent cerebrovascular accident, severe cardiac insufficiency * Diabetic patient (Type I and II) * Patient with medical or surgical antecedents * Patient receiving treatment with amantadine, ketamine, dextrometorphan, L-Dopa, dopaminergic, anticholinergic agonists, barbiturate, neuroleptic, IMAO, antispastic agents, dantrolen or baclofen, phenitoin, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide, warfarine * Patient with alcohol addiction * Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman * Patient who participated in another clinical trial, located in exclusion period or received benefits \> 4500 euros during 12 months before the beginning of trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| average painful intensity | 5 days before visit of 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of pain by numerical scale | during 15 first days following surgery and to visit of 3 months |
| Average painful | on 5 days before visit of 6 months post-surgery |
| analgesic consumption | during 3 months after surgery |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGisèle PICKERING
University Hospital, Clermont-Ferrand
Outcome results
None listed