NCT00004408

Phase III Randomized Study of Poloxamer 188 for Vaso-Occlusive Crisis of Sickle Cell Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: Mast Therapeutics, Inc. · Industry
• Sex: All
• Age: 10 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sickle Cell Anemia

Interventions

Type	Name	Description
DRUG	poloxamer 188

Timeline

• Start date: 1997-11-01
• Completion: 1999-11-01
• First posted: 1999-10-19
• Last updated: 2012-03-06