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

This study has been completed.
Sponsor:
Information provided by:
Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00598559
First received: January 8, 2008
Last updated: November 11, 2010
Last verified: November 2010
Results First Received: September 25, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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  
Number of Participants  
[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
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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


  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.


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 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.  


Results Point of Contact:  
Name/Title: Mike Royal. MD, JD, MBA. Vice President Clinical Development- Analgesics
Organization: Cadence Pharmaceuticals, Inc
phone: 858 436 1400
e-mail: mroyal@cadencepharm.com


No publications provided


Responsible Party: Cadence Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00598559     History of Changes
Other Study ID Numbers: CPI-APA-351
Study First Received: January 8, 2008
Results First Received: September 25, 2009
Last Updated: November 11, 2010
Health Authority: United States: Food and Drug Administration