Back to resultsImpact of Oral Magnesium on Neuropathic Pain
Primary Purpose
Patient With Neuropathic Pain
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Magnogene ® (magnesium)
Sponsored by
About this trial
This is an interventional treatment trial for Patient With Neuropathic Pain focused on measuring Neuropathic pain, magnesium
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
Sites / Locations
- CHU Clermont-Ferrand
Outcomes
Primary Outcome Measures
Pain scores (neuropathic pain evaluation questionnaire)
Secondary Outcome Measures
- Numeric scale - quality o f life questionnaires
Full Information
NCT ID
NCT01121653
First Posted
May 10, 2010
Last Updated
May 10, 2010
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT01121653
Brief Title
Impact of Oral Magnesium on Neuropathic Pain
Official Title
Impact of Oral Magnesium on Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient With Neuropathic Pain
Keywords
Neuropathic pain, magnesium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Magnogene ® (magnesium)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain scores (neuropathic pain evaluation questionnaire)
Time Frame
Visit D0
Secondary Outcome Measure Information:
Title
- Numeric scale - quality o f life questionnaires
Time Frame
Visit Week 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisèle PICKERING, MCU-PH
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Learn more about this trial
Impact of Oral Magnesium on Neuropathic Pain
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