Impact of Oral Magnesium on Neuropathic Pain | NCT01121653

Studies
Impact of Oral Magnesium on Neuropathic Pain

NCT01121653

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

May 12, 2010Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Patient With Neuropathic Pain

Interventions

Magnogene ® (magnesium)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Jan 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

May 10, 2010

First Submission Date that Met QC Criteria

May 10, 2010

First Posted Date

May 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2010

Last Update Posted Date

May 12, 2010Estimated

Description Module

Brief Summary

Use lay language.

The aim of this study is to evaluate on pain scores (neuropathic pain questionnaire and pain numeric scale) and on quality of life, the effect of oral magnesium intake on patients with neuropathic pain comparing with patients receiving placebo,. The study drug will be taken during 4 weeks.

Detailed Description

Protocol description

Visit D0

patient inclusion after informed signed consent
clinical exam
blood sampling (magnesium dosage)
questionnaires (neuropathic pain and quality of life)
daily self-evaluation on neuropathic pain scale (Week0 to Week5)

D8 : first intake of study drug (magnesium or placebo)

Visit Week5:

questionnaires (neuropathic pain and quality of life)
blood sampling (magnesium dosage)
clinical exam

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnogene ® (magnesium)	Drug	evaluate on pain scores (neuropathic pain questionnaire and pain numeric scale) and on quality of life, the effect of oral magnesium intake on patients with neuropathic pain comparing with patients receiving placebo,. The study drug will be taken during 4 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain scores (neuropathic pain evaluation questionnaire)		Visit D0

Secondary Outcomes

Measure	Description	Time Frame
- Numeric scale - quality o f life questionnaires		Visit Week 5

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- neuropathic pain

- informed signed consent

Exclusion Criteria:

magnesium intake contra-indication
severe renal insufficiency
quinidine intake
concomitant treatment change 2weeks before inclusion
evolutive pathology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gisèle PICKERING, MCU-PH	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand		Clermont-Ferrand		63003	France

Condition Browse Module

MeSH Terms

ID	Term
D009437	Neuralgia

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008274	Magnesium

Ancestor Terms

ID	Term
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D019565	Metals, Light

Browse Leaves

Not provided

Browse Branches

Not provided