Impact of Oral Magnesium on Neuropathic Pain

May 10, 2010 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

May 10, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (ESTIMATE)

May 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2010

Last Update Submitted That Met QC Criteria

May 10, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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