Phase III Randomized Study of Sodium Dichloroacetate in Children With Congenital Lactic Acidosis
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|ClinicalTrials.gov Identifier: NCT00004490|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Lactic Acidosis||Drug: sodium dichloroacetate||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||45 participants|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||October 1998|
|Study Completion Date :||September 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004490
|Study Chair:||Peter W. Stacpoole||University of Florida|