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Sponsors and Collaborators: |
Emmaus Medical, Inc. FDA Office of Orphan Products Development |
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Information provided by: | Emmaus Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT00125788 |
The primary purpose of this study is to evaluate the effectiveness of oral L-glutamine in the therapy of sickle cell anemia and sickle ß0-thalassemia.
The secondary purpose is to assess the effect of L-glutamine on pain; energy and appetite levels; narcotics usage; height and weight; and hospital and emergency room visits for sickle cell pain.
Condition | Intervention | Phase |
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Sickle Cell Anemia Thalassemia |
Drug: L-glutamine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of L Glutamine Therapy for Sickle Cell Anemia and Sickle ß0-Thalassemia |
Estimated Enrollment: | 80 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | May 2008 |
Ages Eligible for Study: | 5 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be eligible to participate in the study, a patient must meet all of the following inclusion criteria:
Exclusion Criteria:
If the patient meets any of the following criteria, the patient must not be enrolled:
United States, California | |
Harbor-UCLA Medical Center | |
Torrance, California, United States, 90502 | |
Kaiser Permanente | |
Bellflower, California, United States, 90706 | |
United States, Georgia | |
Grady Memorial Hospital | |
Atlanta, Georgia, United States, 30303 | |
United States, New Jersey | |
University of Medicine and Dentistry, New Jersey | |
New Brunswick, New Jersey, United States, 08903 | |
United States, New York | |
Jacobi Medical Center | |
Bronx, New York, United States, 10461 |
Principal Investigator: | Yutaka Niihara, MD | CEO, Emmaus Medical, Inc |
Study ID Numbers: | 10478 |
Study First Received: | August 1, 2005 |
Last Updated: | April 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00125788 |
Health Authority: | United States: Food and Drug Administration |
sickle cell disease sickle cell anemia L-glutamine Sickle Cell Anemia (homozygous) Sickle ß0-Thalassemia |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies Anemia |
Anemia, Hemolytic Hemoglobinopathy Thalassemia Anemia, Sickle Cell Sickle cell anemia |