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Preventing the Development of Neuropathic Pain Post-mastectomy/Tumorectomy by Pre-emptive or Post-operative Memantine Administration


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Neuropathic Pain

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Trial Information

Preventing the Development of Neuropathic Pain Post-mastectomy/Tumorectomy by Pre-emptive or Post-operative Memantine Administration


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

average painful intensity

Outcome Time Frame:

5 days before visit of 3 months

Safety Issue:

Yes

Principal Investigator

Gisèle PICKERING

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Clermont-Ferrand

Authority:

France: Ministry of Health

Study ID:

CHU-0115

NCT ID:

NCT01536314

Start Date:

February 2012

Completion Date:

December 2013

Related Keywords:

  • Neuropathic Pain
  • Pre-emptive administration
  • Post-operative administration
  • Prophylaxis
  • Memantine
  • Post-mastectomy/tumorectomy
  • Neuropathic pain
  • Neuralgia

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