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Phase III Randomized Study of Sodium Dichloroacetate in Children With Congenital Lactic Acidosis

NCT00004490 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2015-03-25

No results posted yet for this study

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.

Conditions

  • Lactic Acidosis

Interventions

DRUG

sodium dichloroacetate

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Peter W. Stacpoole · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-10-31
Completion
2002-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004490 on ClinicalTrials.gov