Impact of Oral Magnesium on Neuropathic Pain

Patient With Neuropathic Pain Clinical Trial

Official title:

Impact of Oral Magnesium on Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121653
• Other study ID #: CHU-0073
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2010
• Last updated: May 10, 2010
• Start date: March 2006
• Est. completion date: June 2008

Study information

• Verified date: May 2010
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Patient With Neuropathic Pain

Intervention

Drug:
• Magnogene ® (magnesium)
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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores (neuropathic pain evaluation questionnaire)		Visit D0	Yes
Secondary	- Numeric scale - quality o f life questionnaires		Visit Week 5	Yes