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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:
CytRx
Information provided by (Responsible Party):
Mast Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 18, 1999
First Posted Date  ICMJE October 19, 1999
Last Update Posted Date March 6, 2012
Study Start Date  ICMJE November 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Randomized Study of Poloxamer 188 for Vaso-Occlusive Crisis of Sickle Cell Disease
Official Title  ICMJE Not Provided
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Anemia
Intervention  ICMJE Drug: poloxamer 188
Study Arms  ICMJE Not Provided
Publications * Adams-Graves P, Kedar A, Koshy M, Steinberg M, Veith R, Ward D, Crawford R, Edwards S, Bustrack J, Emanuele M. RheothRx (poloxamer 188) injection for the acute painful episode of sickle cell disease: a pilot study. Blood. 1997 Sep 1;90(5):2041-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
300
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1999
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004408
Other Study ID Numbers  ICMJE 199/13296
CYTRX-C97-1248
CYTRX-FDR001433
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mast Therapeutics, Inc.
Study Sponsor  ICMJE Mast Therapeutics, Inc.
Collaborators  ICMJE CytRx
Investigators  ICMJE
Study Chair: R. Martin Emanuele CytRx
PRS Account Mast Therapeutics, Inc.
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP