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Sponsors and Collaborators: |
Baylor College of Medicine Texas Children's Hospital Children's Hospital Boston |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00040456 |
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.
Condition | Intervention | Phase |
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Hemoglobin SC Disease |
Drug: Mg Pidolate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Oral Magnesium Pidolate on Incidence of Painful Crises in Patients With Hemoglobin SC Disease |
Estimated Enrollment: | 20 |
Study Start Date: | March 2000 |
Estimated Study Completion Date: | May 2005 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Exclusion Criteria:
United States, Massachusetts | |
Children's Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 |
Study Chair: | Brigitta Mueller, MD | Baylor College of Medicine |
Study ID Numbers: | H9251, MG Pidolate |
Study First Received: | June 26, 2002 |
Last Updated: | April 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00040456 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies Hemoglobin SC Disease |
Anemia Anemia, Hemolytic Pain Hemoglobinopathy Anemia, Sickle Cell |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies |
Hemoglobin SC Disease Anemia Anemia, Hemolytic Anemia, Sickle Cell |