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Poloxamer 188 for Vaso-Occlusive Crisis of Sickle Cell Disease
NCT00004408Phase 3
Key facts
- Status
- Completed
- Start
- Nov 1997
- Sponsor
- Mast Therapeutics, Inc.
- Modality
- Polymer-based Nanoparticles, Device-based Delivery, Small Molecules
- Drugs
- poloxamer 188
- Conditions
- vaso-occlusive crisis (VOC)
01
Overview
Phase 3, randomised, double-blind trial in vaso-occlusive crisis (VOC) comparing Poloxamer 188 Arm with Placebo Arm (2 arms). Primary endpoint: Duration of the painful episode, from randomization to crisis resolution. Started Nov 1997; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Poloxamer 188 Arm
Placebo Arm
03
Who it enrols
Inclusion of patients with confirmed sickle cell disease experiencing a severe, acute painful crisis requiring hospitalization and parenteral analgesics. Exclusion criteria include recent major surgery, use of concurrent investigational or nonsteroidal anti-inflammatory drugs, prior poloxamer 188 therapy, significant organ dysfunction (hepatic, renal, cardiovascular), recent stroke or seizure, pregnancy, or life-threatening complications of a crisis.
04
Endpoints
Primary
Duration of the painful episode, from randomization to crisis resolution
Secondary
Intensity of pain
Total analgesic use
Length of hospitalization
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