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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 scale

Average 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

Page last updated: August 23, 2015

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