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Effect on Acetaminophen Metabolism by Liquid Formulations

This study has been completed.
Sponsor:
Collaborators:
Harvard University
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01246713
First received: November 22, 2010
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
Results First Received: February 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Conditions: Acetaminophen Metabolism
Acetaminophen Poisoning
Drug Metabolism by Excipients
Interventions: Drug: Acetaminophen liquid formulation
Drug: Acetaminophen solid formulation

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Study Participants All study participants received a 15mg/kg dose of a solid acetaminophen formulation and a 15mg/kg dose of a liquid acetaminophen formulation separated by at least a 2 week washout period. Whether they received the solid or liquid preparation initially was randomly chosen.

Participant Flow:   Overall Study
    All Study Participants  
STARTED     15  
COMPLETED     15  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
All Study Participants All study participants received a 15mg/kg dose of a solid acetaminophen formulation and a 15mg/kg dose of a liquid acetaminophen formulation separated by at least a 2 week washout period.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
 		  15  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     5  
Male     10  
Region of Enrollment  
[units: participants]
 		 
United States     15  



  Outcome Measures

1.  Primary:   Acetaminophen Metabolites   [ Time Frame: 8 hours ]
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  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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
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Results Point of Contact:  
Name/Title: Michael Ganetsky, MD
Organization: BIDMC
phone: 6177542323
e-mail: mganetsk@bidmc.harvard.edu


No publications provided by Beth Israel Deaconess Medical Center

Publications automatically indexed to this study:


Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01246713     History of Changes
Other Study ID Numbers: 2010P-000135, UL1RR025758
Study First Received: November 22, 2010
Results First Received: February 18, 2013
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board