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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004408
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 6, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Drug: poloxamer 188 Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : November 1997
Study Completion Date : November 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Sickle cell disease confirmed by electrophoresis or high pressure liquid chromatography
  • At least one prior documented painful crisis episode but no greater than 10 crises per year for the last two years
  • Sudden onset of acute pain lasting 4-12 hours and involving at least one site
  • Severe crisis pain that requires parenteral analgesics and hospitalization, but not within the preceding 2 weeks

--Prior/Concurrent Therapy--

  • Surgery: At least 2 weeks since prior major surgery No concurrent surgery
  • Other: At least 2 weeks since prior puncture of noncompressible vessels No prior therapy using poloxamer 188 No concurrent investigational drug No concurrent use of nonsteroidal anti-inflammatory drugs

--Patient Characteristics--

  • Hematopoietic: No significant bleeding or bleeding disorder
  • Hepatic: ALT no greater than 2 times normal
  • Renal: No active renal disease Creatinine no greater than 1.0 mg/dL OR Creatinine clearance greater than 50 mL/min Protein less than 300 mg/dL
  • Cardiovascular: No evidence of acute myocardial ischemia or infarction
  • Neurologic: At least 6 months since prior cerebrovascular accident or seizure
  • Other: Not pregnant Fertile patients must use effective contraception during and for at least 30 days after treatment No history of chronic bacterial osteomyelitis No history of drug or alcohol abuse At least 6 months since prior use of illicit drug Have adequate IV access No crisis with life-threatening complications such as: Hepatic or splenic sequestration Acute chest syndrome Aplastic crisis No known infection or infection with encapsulated organism No evidence of septic shock Not concurrently hospitalized for other conditions Not concurrently on hypertransfusion program
Contacts and Locations

Information from the National Library of Medicine

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


Sponsors and Collaborators
Mast Therapeutics, Inc.
CytRx
Investigators
Study Chair: R. Martin Emanuele CytRx
More Information

Publications:
Responsible Party: Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00004408     History of Changes
Other Study ID Numbers: 199/13296
CYTRX-C97-1248
CYTRX-FDR001433
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: March 2012

Keywords provided by Mast Therapeutics, Inc.:
disease-related problem/condition
genetic diseases and dysmorphic syndromes
hematologic disorders
pain
rare disease
sickle cell anemia

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn