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

This study has been completed.
Sponsor:
Collaborator:
CytRx
Information provided by (Responsible Party):
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00004408
First received: October 18, 1999
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

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
Sickle Cell Anemia
Drug: poloxamer 188
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Mast Therapeutics, Inc.:

Estimated Enrollment: 300
Study Start Date: November 1997
Study Completion Date: November 1999
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.

  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 18, 1999
Last Updated: March 5, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 29, 2014