NCT01536314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

1.8 years

First QC Date

February 16, 2012

Last Update Submit

June 30, 2014

Conditions

Neuropathic Pain

Keywords

Pre-emptive administrationPost-operative administrationProphylaxisMemantinePost-mastectomy/tumorectomyNeuropathic pain

Outcome Measures

Primary Outcomes (1)

  • average painful intensity

    5 days before visit of 3 months

Secondary Outcomes (3)

  • 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

Interventions

Memantine EBIXA®DRUG

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.

Placebo : lactoseDRUG

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 Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

  • Morel V, Joly D, Villatte C, Dubray C, Durando X, Daulhac L, Coudert C, Roux D, Pereira B, Pickering G. Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients. PLoS One. 2016 Apr 6;11(4):e0152741. doi: 10.1371/journal.pone.0152741. eCollection 2016.

    PMID: 27050431DERIVED

  • Pickering G, Morel V, Joly D, Villatte C, Roux D, Dubray C, Pereira B. Prevention of post-mastectomy neuropathic pain with memantine: study protocol for a randomized controlled trial. Trials. 2014 Aug 20;15:331. doi: 10.1186/1745-6215-15-331.

    PMID: 25142039DERIVED

MeSH Terms

Conditions

Neuralgia

Interventions

Memantine

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Gisèle PICKERING

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 22, 2012

Study Start

February 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

July 1, 2014

Record last verified: 2014-06

Locations

FR(1)