Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004408
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
1999-10-18
Brief Title:
Phase III Randomized Study of Poloxamer 188 for Vaso-Occlusive Crisis of Sickle Cell Disease
Sponsor:
Mast Therapeutics Inc
Organization:
Mast Therapeutics Inc
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CYTRX-FDR001433 | None | None | None |
| CYTRX-C97-1248 | None | None | None |