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Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598559
First Posted: January 22, 2008
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mallinckrodt
Results First Submitted: September 25, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute Pain
Fever
Intervention: Drug: IV Acetaminophen

  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
Open label study conducted in the US from 21 Feb 2008 -12 Aug 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IV Acetaminophen 1 Gram Every 6 Hours All Subjects Randomized to Receive IV acetaminophen 1 gram administered every 6 hours.
IV Acetaminophen 650 Milligram Every 4 Hours All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
Standard of Care (SOC) All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.

Participant Flow:   Overall Study
    IV Acetaminophen 1 Gram Every 6 Hours   IV Acetaminophen 650 Milligram Every 4 Hours   Standard of Care (SOC)
STARTED   92   91   30 
COMPLETED   65 [1]   63 [1]   27 [1] 
NOT COMPLETED   27   28   3 
Adverse Event                11                7                0 
Withdrawal by Subject                2                2                0 
Protocol Non-compliance                1                0                0 
Early discharge from hospital                9                12                3 
Subject unable/unwilling to attend visit                4                7                0 
[1] Subjects completed 5 days of treatment



  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
IV Acetaminophen 1g q6h All Subjects Randomized to Receive IV acetaminophen 1g administered every 6 hours.
IV Acetaminophen 650 mg q4h All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
Standard of Care (SOC) All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
Total Total of all reporting groups

Baseline Measures
   IV Acetaminophen 1g q6h   IV Acetaminophen 650 mg q4h   Standard of Care (SOC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 92   91   30   213 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   48   54   17   119 
>=65 years   44   37   13   94 
Gender 
[Units: Participants]
       
Female   49   44   17   110 
Male   43   47   13   103 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).   [ Time Frame: T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up ]

2.  Primary:   Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)   [ Time Frame: First dose (T0) to within 30 days of the last dose of study medication. ]

3.  Secondary:   Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments   [ Time Frame: End of Day 5 (prior to discharge) ]

4.  Secondary:   Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.   [ Time Frame: Study period lookback at Day 7 ]


  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
No separate efficacy analyses were performed for the fever because only 1 subject in each active group had fever as an indication, and no subject had both pain and fever as indications for treatment with IV acetaminophen.


  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: NCT00598559     History of Changes
Other Study ID Numbers: CPI-APA-351
First Submitted: January 8, 2008
First Posted: January 22, 2008
Results First Submitted: September 25, 2009
Results First Posted: December 10, 2010
Last Update Posted: October 21, 2016