Prophylaxis of Neuropathic Pain by mémantine

Phase 3

Completed

• Conditions: Neuropathic Pain

• Registration Number: NCT01536314
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-22
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
average painful intensity	5 days before visit of 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France