Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004797
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Pilot Study of Fructose for Sickle Cell Crisis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
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 Evaluate the efficacy and tolerability of fructose administered every 6 hours for up to 72 hours to patients in active sickle cell crisis
II Obtain tolerability information in selected patients treated with fructose for more than 72 hours
II Obtain tolerability information in selected patients treated with fructose for more than 72 hours
Detailed Description:
PROTOCOL OUTLINE In the first part of the study patients are block-randomized 31 to a single intravenous dose of fructose or placebo The dose of fructose is escalated in each successive group after tolerability data are evaluated
In the second part of the study patients are randomly assigned 11 to fructose or placebo administered intravenously every 6 hours for 72 hours The dose of fructose is the highest well-tolerated dose determined in Study 1 or the most tolerated dose for the patient Patients who just completed Study 1 may participate if they are clearly in a separate crisis and continue to meet entry criteria
Patients whose symptoms persist for more than 72 hours after fructose or placebo are eligible to receive additional fructose every 6 hours until symptoms subside
In the second part of the study patients are randomly assigned 11 to fructose or placebo administered intravenously every 6 hours for 72 hours The dose of fructose is the highest well-tolerated dose determined in Study 1 or the most tolerated dose for the patient Patients who just completed Study 1 may participate if they are clearly in a separate crisis and continue to meet entry criteria
Patients whose symptoms persist for more than 72 hours after fructose or placebo are eligible to receive additional fructose every 6 hours until symptoms subside
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NU-573 | None | None | None |