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

NCT00004408 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2012-03-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

poloxamer 188

Sponsors & Collaborators

  • CytRx

    collaborator INDUSTRY

  • Mast Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • R. Martin Emanuele · CytRx

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
10 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-11-30
Completion
1999-11-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004408 on ClinicalTrials.gov