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NCT00040456 · ClinicalTrials.gov registry record · Phase 2
Oral Magnesium Pidolate, Hemoglobin SC Disease, MG Pidolate
A Phase 2 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00040456 is a Phase 2 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 12 participants.
The verdict
NCT00040456, a Phase 2 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
Subjects have a form of sickle cell disease, called hemoglobin SC disease. This results in abnormally shaped red blood cells that get 'stuck' in blood vessels and then results in episodes of severe pain (pain crises). Patients with the more common form of sickle cell disease, called hemoglobin SS disease, also suffer from pain crises. Treatment with the drug hydroxyurea is available to help prevent the pain crises in hemoglobin SS disease, but there is no good treatment to help prevent the pain crises in hemoglobin SC disease. It has been shown that one of the reasons for the formation of the abnormally shaped red blood cells in patients with SC disease is the fact that these cells do not contain enough water; they are dehydrated. Drinking more water will not increase the amount of water in the cells. Certain salts and minerals can however have an effect on the amount of water in the red blood cells. One of the most important minerals influencing this is called magnesium. Magnesium is present in food and also in certain medications used to treat heartburn. Magnesium has been used successfully both in animals and people to increase the amount of water in the red blood cells and is very well tolerated by most people. Investigators are using a new form of magnesium known as magnesium pidolate because this form of magnesium may help with the symptoms of disease without causing diarrhea (a common side effect of magnesium products). Purpose 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. The study will last for about 64 weeks (about 16 months).
Interventions
- DRUG Placebo
- DRUG Mg Pidolate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2001-01 |
| Est. Completion | 2006-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00040456
The ClinicalTrials.gov registry entry for NCT00040456 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00040456 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00040456 about?
NCT00040456 is a clinical study titled "Oral Magnesium Pidolate, Hemoglobin SC Disease, MG Pidolate". Subjects have a form of sickle cell disease, called hemoglobin SC disease. This results in abnormally shaped red blood cells that get 'stuck' in blood vessels and then results in episodes of severe pain (pain crises). Patients with the more common form of sickle cell disease, called hemoglobin SS di...
What is the current status of trial NCT00040456?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2001-01. Estimated completion is 2006-05.
What interventions are being tested in trial NCT00040456?
The interventions under investigation include: Placebo (DRUG), Mg Pidolate (DRUG).
Who is sponsoring clinical trial NCT00040456?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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