Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
43 participants
INTERVENTIONAL
2012-02-29
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Interventions
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Memantine 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.
Placebo : 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.
Eligibility Criteria
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Inclusion Criteria
* patient suffering breast cancer with mastectomy/tumorectomy with or within cleaning 2 weeks after inclusion with or within pre-emptive chemotherapy
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Gisèle PICKERING
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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References
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Morel V, Joly D, Villatte C, Dubray C, Durando X, Daulhac L, Coudert C, Roux D, Pereira B, Pickering G. Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients. PLoS One. 2016 Apr 6;11(4):e0152741. doi: 10.1371/journal.pone.0152741. eCollection 2016.
Pickering G, Morel V, Joly D, Villatte C, Roux D, Dubray C, Pereira B. Prevention of post-mastectomy neuropathic pain with memantine: study protocol for a randomized controlled trial. Trials. 2014 Aug 20;15:331. doi: 10.1186/1745-6215-15-331.
Other Identifiers
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CHU-0115
Identifier Type: -
Identifier Source: org_study_id
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