Phase III Randomized Study of Poloxamer 188 for Vaso-Occlusive Crisis of Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT00004408|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 6, 2012
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 or disease||Intervention/treatment||Phase|
|Sickle Cell Anemia||Drug: poloxamer 188||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||300 participants|
|Study Start Date :||November 1997|
|Actual Study Completion Date :||November 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004408
|Study Chair:||R. Martin Emanuele||CytRx|