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NCT00004493 · ClinicalTrials.gov registry record · Phase 2

Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia

A Phase 2 study, sponsored by University of California, San Diego.

Completed
Registry status
Phase 2
Development phase
75
Enrollment target

NCT00004493 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 75 participants.

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The verdict

NCT00004493, a Phase 2 study, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
Phase 2
Development phase
75 participants
Enrollment target

Study Summary

OBJECTIVES: I. Determine the pharmacokinetics of sodium dichloroacetate (DCA) in patients with congenital lactic acidemia. II. Determine the efficacy of DCA in decreasing the frequency and/or severity of acute episodes of acidotic illness, improving linear growth, improving neurological or developmental function, or slowing neurological or developmental deterioration in these patients.

Interventions

  • DRUG sodium dichloroacetate

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 1998-09
Est. Completion 2003-09
Phase Phase 2

Sponsor

University of California, San Diego

775 total trials

What the Registry Record Tells You About NCT00004493

The ClinicalTrials.gov registry entry for NCT00004493 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which sodium dichloroacetate is the first listed.

NCT00004493 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00004493 about?

NCT00004493 is a clinical study titled "Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia". OBJECTIVES: I. Determine the pharmacokinetics of sodium dichloroacetate (DCA) in patients with congenital lactic acidemia. II. Determine the efficacy of DCA in decreasing the frequency and/or severity of acute episodes of acidotic illness, improving linear growth, improving neurological or developm...

What is the current status of trial NCT00004493?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 1998-09. Estimated completion is 2003-09.

What interventions are being tested in trial NCT00004493?

The interventions under investigation include: sodium dichloroacetate (DRUG).

Who is sponsoring clinical trial NCT00004493?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.