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Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis Clinical research trials and Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis. Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis clinical trial. Subjects often receive the most expert healthcare possible for their Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis  Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis
Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis
For Condition: Lactic Acidosis
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , University of Florida
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Crossover Assignment
Minimum Age/Maximum Age: 3 Months/18 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of congenital lactic acidosis (CLA) meeting the following criteria: Three basal venous lactates at least 2.5 mM, arterial lactates at least 2.0 mM, or CSF lactates at least 2.5 mM OR any combination of these, obtained over at least 1 month and within 6 months OR Increase in blood lactate at least 1.0 mM over basal following a carbohydrate meal challenge AND Enzymatic or molecular genetic proof of a defect of pyruvate dehydrogenase complex, one or more respiratory chain enzymes, or a Krebs cycle enzyme OR Over production of C14-lactate from C14-glucose by cultured skin fibroblasts AND Ability to withstand an 8 hour (if 2 years and under) or 12 hour (if over 2 years) fast without developing hypoglycemia (blood glucose less than 50 mg/dL) No secondary lactic acidosis due to impaired oxygenation or circulation No hyperlactatemia associated with proven biotinidase deficiency (biotin responsive CLA) or with enzyme deficiencies of gluconeogenesis No primary, defined organic acidurias other than lactic acidosis, for which effective therapy is available (e.g., propionic aciduria) No primary disorders of amino acid metabolism or fatty acid oxidation No malabsorption syndromes associated with D-lactic acidosis --Prior/Concurrent Therapy-- No chronic dialysis --Patient Characteristics-- Hepatic: No primary hepatic disease unrelated to CLA Renal: Creatinine less than 1.2 mg/dL OR Creatinine clearance at least 60 mL/min Other: No concurrent infection or fever
Total Enrollment: 45
Location and Contact Information:
Overall Study Official:
PeterStacpoole, Study Chair, University of Florida
Additional Information:
Study ID Numbers: 199/14271; UF-G-FDR001500,UF-G-183-92
Study Start Date: October 1998
Record last reviewed: April 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004490
Other Lactic Acidosis Studies:
1. Study of the Metabolism of Pyruvate and Related Problems in Patients with Lactic Acidemia
2. Dichloroacetate Kinetics, Metabolism and Toxicology
3. Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia
4. Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis
Related Studies:
Other Lactic Acidosis Clinical Trials
Other Clinical Trials
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Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis
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