Prophylaxis of Neuropathic Pain by mémantine
Information source: University Hospital, Clermont-Ferrand
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuropathic Pain
Intervention: Memantine EBIXA® (Drug); Placebo : lactose (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University Hospital, Clermont-Ferrand Official(s) and/or principal investigator(s): Gisèle PICKERING, Principal Investigator, Affiliation: University Hospital, Clermont-Ferrand
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.
Clinical Details
Official title: Preventing the Development of Neuropathic Pain Post-mastectomy/Tumorectomy by Pre-emptive or Post-operative Memantine Administration
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: average painful intensity
Secondary outcome: Evaluation of pain by numerical scaleAverage painful analgesic consumption
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
CHU Clermont-Ferrand, Clermont-Ferrand 63003, France
Additional Information
Starting date: February 2012
Last updated: June 30, 2014
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