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

February 16, 2012
October 8, 2012
February 2012
June 2013   (final data collection date for primary outcome measure)
average painful intensity [ Time Frame: 5 days before visit of 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01536314 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prophylaxis of Neuropathic Pain by mémantine
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.

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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Neuropathic Pain
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
France
 
NCT01536314
CHU-0115
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
  • 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
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
October 2012

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