Prophylaxis of Neuropathic Pain by mémantine (MEMANTINE)

This study is currently recruiting participants.

Verified October 2012 by University Hospital, Clermont-Ferrand

Sponsor:

Collaborators:

Dr Xavier DURANDO/Dr Marie-Ange MOURET/Dr Christine VILLATTE, Jean-Perrin Cancer Center, Clermont-Ferrand Hospital

Pr Claude Dubray, Clinical Pharmacology Center, Inserm 501, Clermont-Ferrand Hospital

Information provided by (Responsible Party):

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT01536314

First received: February 16, 2012

Last updated: October 8, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 16, 2012

Last Updated Date

October 8, 2012

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

average painful intensity [ Time Frame: 5 days before visit of 3 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01536314 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluation of pain by numerical scale [ Time Frame: during 15 first days following surgery and to visit of 3 months ] [ Designated as safety issue: Yes ]
Average painful [ Time Frame: on 5 days before visit of 6 months post-surgery ] [ Designated as safety issue: Yes ]
analgesic consumption [ Time Frame: during 3 months after surgery ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prophylaxis of Neuropathic Pain by mémantine

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Neuropathic Pain

Intervention ^ICMJE

Drug: 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.
Drug: 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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Patrick LACARIN

04 73 75 11 95

placarin@chu-clermontferrand.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01536314

Other Study ID Numbers ^ICMJE

CHU-0115

Has Data Monitoring Committee

Not Provided

Responsible Party

University Hospital, Clermont-Ferrand

Study Sponsor ^ICMJE

University Hospital, Clermont-Ferrand

Collaborators ^ICMJE

Dr Xavier DURANDO/Dr Marie-Ange MOURET/Dr Christine VILLATTE, Jean-Perrin Cancer Center, Clermont-Ferrand Hospital
Pr Claude Dubray, Clinical Pharmacology Center, Inserm 501, Clermont-Ferrand Hospital

Investigators ^ICMJE

Principal Investigator:

Gisèle PICKERING

University Hospital, Clermont-Ferrand

Information Provided By

University Hospital, Clermont-Ferrand

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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