Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004490
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Phase III Randomized Study of Sodium Dichloroacetate in Children With Congenital Lactic Acidosis
Sponsor:
University of Florida
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-04
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 Compare the safety of sodium dichloroacetate DCA vs placebo in children with congenital lactic acidosis
II Determine the quality of life of these patients
III Determine the pharmacokinetics and metabolic fate of DCA over the course of drug administration in these patients
I Compare the safety of sodium dichloroacetate DCA vs placebo in children with congenital lactic acidosis
II Determine the quality of life of these patients
III Determine the pharmacokinetics and metabolic fate of DCA over the course of drug administration in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind crossover study Patients are stratified according to age 3 months to 2 years vs over 2 to 18 years
All patients receive at least 12 months of sodium dichloroacetate DCA during a 2 year period of double blind crossover evaluation of DCA and placebo by mouth
Quality of life is assessed before treatment and periodically during treatment
Completion date provided represents the completion date of the grant per OOPD records
All patients receive at least 12 months of sodium dichloroacetate DCA during a 2 year period of double blind crossover evaluation of DCA and placebo by mouth
Quality of life is assessed before treatment and periodically during treatment
Completion date provided represents the completion date of the grant per OOPD records
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 |
|---|---|---|---|
| UF-G-183-92 | None | None | None |
| UF-G-FDR001500 | None | None | None |