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The Effect of Oral Magnesium Pidolate on How Often Painful Crises Happens in Patients With Hemoglobin SC Disease
This study has been completed.
Study NCT00040456   Information provided by Baylor College of Medicine
First Received: June 26, 2002   Last Updated: April 9, 2007   History of Changes

June 26, 2002
April 9, 2007
March 2000
 
 
 
Complete list of historical versions of study NCT00040456 on ClinicalTrials.gov Archive Site
 
 
 
The Effect of Oral Magnesium Pidolate on How Often Painful Crises Happens in Patients With Hemoglobin SC Disease
The Effect of Oral Magnesium Pidolate on Incidence of Painful Crises in Patients With Hemoglobin SC Disease

The purpose of this study is to find out whether treatment with magnesium pidolate will increase the amount of water in the red blood cell and result in fewer painful crises in patients with hemoglobin SC disease while not causing diarrhea.

Patients will be randomly assigned to study medication (Mg pidolate or placebo) for 24 weeks, followed by a washout period of 8 weeks. After the washout period each patient will receive a further 24 weeks of study medication.

Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Hemoglobin SC Disease
Drug: Mg Pidolate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
20
May 2005
 

Inclusion criteria:

This protocol is open to male and female patients of all races with a diagnosis of severe sickle hemoglobinopathy providing they also satisfy the following eligibility criteria:

  • Adult and pediatric patients with Hb SC disease who are able to swallow the Mg pidolate preparation and who have had at least one prior painful crisis.

Exclusion Criteria:

  • Patients transfused within 90 days of study entry,
  • Patients with elevated (>1.5 times upper limit of normal for age) BUN, creatinine, or liver function tests > 3 times the upper limit of normal for age,
  • Patients who take a magnesium-containing medication (Mylanta, Maalox, etc.) on a regular (i.e., more than 2 days per week) basis.
  • Patients with progressive neuromuscular disease or patients who are treated with a calcium channel blocker.
  • Pregnancy
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00040456
 
H9251, MG Pidolate
Baylor College of Medicine
  • Texas Children's Hospital
  • Children's Hospital Boston
Study Chair: Brigitta Mueller, MD Baylor College of Medicine
Baylor College of Medicine
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP