Evaluation of Repeat Administration of Purified Poloxamer 188
NCT ID: NCT02449616
Last Updated: 2016-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
16 participants
INTERVENTIONAL
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study Drug
MST-188
MST-188
Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.
Interventions
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MST-188
Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject age 4 through 65 years
* Subject is experiencing acute pain typical of VOC and requires treatment with parenteral opioid analgesia
* Subject requires hospitalization
Exclusion Criteria
* Subject's laboratory results indicate inadequate organ function
* Subject is pregnant or nursing an infant
* Subject had a painful crisis requiring hospitalization within the preceding 14 days
* Subject has been transfused within the past 14 days
* Subject has complications related to SCD
4 Years
65 Years
ALL
No
Sponsors
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Mast Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Edwin L Parsley, D. O.
Role: STUDY_DIRECTOR
Mast Therapeutics, Inc.
Locations
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Rady Children's Hospital
San Diego, California, United States
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Joe Dimaggio Children's Hospital
Hollywood, Florida, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Iowa Children's Hospital
Iowa City, Iowa, United States
Our Lady of the Lake Children's Hospital
Baton Rouge, Louisiana, United States
Rutgers University
New Brunswick, New Jersey, United States
Medical University of South Carolina
Charleston, South Carolina, United States
T. C. Thompson Children's Hospital
Chattanooga, Tennessee, United States
Countries
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Other Identifiers
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MST-188-04
Identifier Type: -
Identifier Source: org_study_id