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Trial record 1 of 4 for:    ACETAMINOPHEN METABOLISM
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Effect on Acetaminophen Metabolism by Liquid Formulations

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ClinicalTrials.gov Identifier: NCT01246713
Recruitment Status : Completed
First Posted : November 23, 2010
Results First Posted : May 8, 2013
Last Update Posted : May 8, 2017
Sponsor:
Collaborators:
Harvard University
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Michael Ganetsky, Beth Israel Deaconess Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions: Acetaminophen Metabolism
Acetaminophen Poisoning
Drug Metabolism by Excipients
Interventions: Drug: Acetaminophen liquid formulation
Drug: Acetaminophen solid formulation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Whether subjects received the solid or liquid preparation initially was randomly chosen.

Reporting Groups
  Description
Solid Acetaminophen First, Then Liquid Acetaminophen Study participants randomized to receive solid formulation first. They received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.
Liquid Acetaminophen First, Then Solid Acetaminophen Study participants randomized to receive liquid formulation first. They received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.

Participant Flow for 3 periods

Period 1:   First Acetaminophen Dosing (1 Day)
    Solid Acetaminophen First, Then Liquid Acetaminophen   Liquid Acetaminophen First, Then Solid Acetaminophen
STARTED   6   9 
COMPLETED   6   9 
NOT COMPLETED   0   0 

Period 2:   Washout (at Least 14 Days)
    Solid Acetaminophen First, Then Liquid Acetaminophen   Liquid Acetaminophen First, Then Solid Acetaminophen
STARTED   6   9 
COMPLETED   6   9 
NOT COMPLETED   0   0 

Period 3:   Second Acetaminophen Dosing (1 Day)
    Solid Acetaminophen First, Then Liquid Acetaminophen   Liquid Acetaminophen First, Then Solid Acetaminophen
STARTED   6   9 
COMPLETED   6   9 
NOT COMPLETED   0   0 



  Baseline Characteristics

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.
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      15 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  33.3% 
Male      10  66.7% 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures

1.  Primary:   Acetaminophen Metabolites   [ Time Frame: 8 hours ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: Michael Ganetsky, MD
Organization: BIDMC
phone: 6177542323
e-mail: mganetsk@bidmc.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Ganetsky, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01246713     History of Changes
Other Study ID Numbers: 2010P000135
UL1RR025758 ( U.S. NIH Grant/Contract )
First Submitted: November 22, 2010
First Posted: November 23, 2010
Results First Submitted: February 18, 2013
Results First Posted: May 8, 2013
Last Update Posted: May 8, 2017