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Safety of Intravenous Acetaminophen Vs Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00493311
First received: June 27, 2007
Last updated: October 18, 2016
Last verified: October 2016
Results First Received: September 25, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fever
Interventions: Drug: IV Placebo
Drug: IV Acetaminophen
Biological: Reference Standard Endotoxin (RSE)

  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 at a single clinical research facility in the United States during July to September 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects received intravenous endotoxin to induce fever and were then randomized to receive either 1 g acetaminophen in 100 ml intravenous solution or 100 ml placebo solution.

Reporting Groups
  Description
Intravenous (IV) Placebo After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
Intravenous (IV) Acetaminophen 1 g After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution

Participant Flow:   Overall Study
    Intravenous (IV) Placebo   Intravenous (IV) Acetaminophen 1 g
STARTED   29   31 
COMPLETED   27   29 
NOT COMPLETED   2   2 
Need for rescue medication                2                2 



  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.
No text entered.

Reporting Groups
  Description
Intravenous (IV) Placebo After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
Intravenous (IV) Acetaminophen 1 g After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
Total Total of all reporting groups

Baseline Measures
   Intravenous (IV) Placebo   Intravenous (IV) Acetaminophen 1 g   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   31   60 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   29   31   60 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.0  (10.02)   29.7  (7.35)   29.9  (8.67) 
Gender [1] 
[Units: Participants]
     
Female   0   0   0 
Male   29   31   60 
[1] Only male subjects were allowed to participate in the study.
Region of Enrollment 
[Units: Participants]
     
United States   29   31   60 


  Outcome Measures
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1.  Primary:   Weighted Sum of Temperature Differences Over 6 Hours (WSTD6) Assessment of the Antipyretic Effect Over 6 h of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever   [ Time Frame: Baseline (T0) to 6 hours post study drug administration ]

2.  Secondary:   Weighted Sum of Temperature Differences Over 3 Hours (WSTD3) Assessment of the Antipyretic Effect Over 3 Hours of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever.   [ Time Frame: Baseline (T0) to 3 hours ]

3.  Secondary:   Maximum Temperature Change During the Period From T0 to T360 Minutes (6 Hours After Study Drug Administration)   [ Time Frame: Baseline (T0) to 360 minutes (6 hours) post study drug administration ]

4.  Secondary:   The Percentage of Subjects With Temperature Less Than 38 Degrees Celsius at Any Timepoint During the Time From T0 to T360 Minutes (6 Hours After Study Drug Administration)   [ Time Frame: 360 minutes (6 hours after study drug administration) ]

5.  Secondary:   Global Assessment of Treatment at T360 Minutes or Early Termination.   [ Time Frame: Baseline (T0) to 6 hours ]


  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
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Lawrence Hill
Organization: Mallinckrodt Pharmaceuticals
phone: (908) 238-6370
e-mail: lawrence.hill@mallinckrodt.com



Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00493311     History of Changes
Other Study ID Numbers: CPI-APF-302
Study First Received: June 27, 2007
Results First Received: September 25, 2009
Last Updated: October 18, 2016
Health Authority: United States: Food and Drug Administration