Pharmacotoxicology of Trichloroethylene Metabolites

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01128270
First received: May 20, 2010
Last updated: April 8, 2014
Last verified: April 2014
Results First Received: November 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Healthy
Interventions: Drug: Dichloroacetate environmental dose
Drug: Chloral Hydrate environmental dose
Drug: Dichloroacetate therapeutic dose
Drug: Chloral Hydrate therapeutic dose

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited using an ad approved by the Institutional Review Board (IRB) and by undergoing a screening exam to determine eligibility.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 27 total participants, with 4 eligible sessions (periods) for each, with the order to be randomized. As per CT.Gov instructions, the periods are identified by treatment rather than order.There were no planned comparisons between the arms of this pharmacological study. Withdrawals entered but did not reach baseline.

Reporting Groups
  Description
All Subjects The intent was to have all subjects participate in all four sessions (periods). These were environmental chloral hydrate +/- environmental DCA and therapeutic chloral hydrate +/- therapeutic DCA. Patient participation: 4 Sessions (N=2), 3 Sessions (N=1), 2 Sessions (N=6), 1 Session (N=8), 0 Sessions (N=10), Total: N=27 patients participated in 31 sessions.

Participant Flow for 4 periods

Period 1:   Environment Chloral Hydrate and DCA (1A)
    All Subjects  
STARTED     7  
COMPLETED     7  
NOT COMPLETED     0  

Period 2:   Environmental Chloral Hydrate (1B)
    All Subjects  
STARTED     8 [1]
COMPLETED     8  
NOT COMPLETED     0  
[1] Per the suggestion from Heather, periods are not in chronological order, but defined by treatment.

Period 3:   Therapeutic Chloral Hydrate and DCA (2A)
    All Subjects  
STARTED     8  
COMPLETED     8  
NOT COMPLETED     0  

Period 4:   Therapeutic Chloral Hydrate (2B)
    All Subjects  
STARTED     8  
COMPLETED     8  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Withdrawals before their treatment was to begin, as all were scheduled to participate in all 4 participate.

Reporting Groups
  Description
All Subjects Intent was to have all subjects participate in all sessions (periods)

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  27  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     27  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  28.0  ± 7.9  
Gender  
[units: participants]
 
Female     15  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     27  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A.   [ Time Frame: 6 Days ]

2.  Primary:   Difference in Half Lives 5 Day Less One Day Exposure in Trichloroacetate   [ Time Frame: 5 days ]

3.  Primary:   Urinary Maleylacetone Levels After 5 Day Exposure to Therapeutic Chloral Hydrate (Arm 2B)   [ Time Frame: 5 days ]

4.  Secondary:   Detectable DCA After Day 1 in Serum (0=No 1=Yes)   [ Time Frame: 1 day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Subjects were asked to wait 30 days in between doses of medication. Some of the participants could not wait the entire 4 months to finish the study and thus dropped out before they completed the 4 arms. Ten were enrolled, screened, but did not start


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter W. Stacpoole,MD
Organization: University of Florida
phone: (352) 273-9023
e-mail: pws@ufl.edu


No publications provided


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01128270     History of Changes
Other Study ID Numbers: IRB#107-10, RO1ESO141617
Study First Received: May 20, 2010
Results First Received: November 20, 2013
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration