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Impact of Oral Magnesium on Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01121653
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : May 12, 2010
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Patient With Neuropathic Pain Drug: Magnogene ® (magnesium) Phase 4

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  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Impact of Oral Magnesium on Neuropathic Pain
Study Start Date : March 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium
U.S. FDA Resources


Intervention Details:
    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.


Primary Outcome Measures :
  1. Pain scores (neuropathic pain evaluation questionnaire) [ Time Frame: Visit D0 ]

Secondary Outcome Measures :
  1. - Numeric scale - quality o f life questionnaires [ Time Frame: Visit Week 5 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121653


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Gisèle PICKERING, MCU-PH University Hospital, Clermont-Ferrand

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01121653     History of Changes
Other Study ID Numbers: CHU-0073
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: May 12, 2010
Last Verified: May 2010

Keywords provided by University Hospital, Clermont-Ferrand:
Neuropathic pain, magnesium

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms