Impact of Oral Magnesium on Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01121653
First received: May 10, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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 Intervention Phase
Patient With Neuropathic Pain
Drug: Magnogene ® (magnesium)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Impact of Oral Magnesium on Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Pain scores (neuropathic pain evaluation questionnaire) [ Time Frame: Visit D0 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • - Numeric scale - quality o f life questionnaires [ Time Frame: Visit Week 5 ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: March 2006
Study Completion Date: June 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01121653     History of Changes
Other Study ID Numbers: CHU-0073
Study First Received: May 10, 2010
Last Updated: May 10, 2010
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on August 28, 2014