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Sponsors and Collaborators: |
FDA Office of Orphan Products Development CytRx |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004408 |
OBJECTIVES: I. Assess the efficacy of poloxamer 188 in reducing the duration of painful vaso-occlusive crisis in patients with sickle cell disease.
II. Assess the effect of poloxamer 188 on duration and intensity of pain, total analgesic use, and length of hospitalization of these patients.
Condition | Intervention | Phase |
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Sickle Cell Anemia |
Drug: poloxamer 188 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study |
Estimated Enrollment: | 300 |
Study Start Date: | November 1997 |
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to hydroxyurea use.
Patients are randomized to treatment poloxamer 188 or placebo. Treatment begins within 12 hours of presentation with crisis. Patients receive poloxamer 188 or placebo by continuous infusion for 48 hours. Pain is assessed before, during, and after treatment.
Patients are followed on days 7-14 and 28-35.
Ages Eligible for Study: | 10 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Study ID Numbers: | 199/13296, CYTRX-C97-1248, CYTRX-FDR001433 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004408 |
Health Authority: | United States: Federal Government |
disease-related problem/condition genetic diseases and dysmorphic syndromes hematologic disorders |
pain rare disease sickle cell anemia |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies Rare Diseases Anemia |
Anemia, Hemolytic Pain Hemoglobinopathy Anemia, Sickle Cell Sickle cell anemia |