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Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery

This study has been completed.
Sponsor:
Information provided by:
Cadence Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00399568
First received: November 14, 2006
Last updated: December 9, 2010
Last verified: December 2010
History of Changes
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
Conditions: Postoperative Pain
Hysterectomy
Interventions: Drug: IV Acetaminophen
Drug: IV Placebo 100 mL solution

  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
Gynecologists and/or anesthesiologists were selected to participate as Principal Investigators.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were required to meet eligibility criteria prior to surgery and then again had to meet post surgical inclusion criteria.Subjects had to achieve a sufficient pain intensity score prior to entering the study.

Reporting Groups
  Description
IV Acetaminophen 1 g/100 mL Solution All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
IV Placebo 100 mL Solution All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.

Participant Flow:   Overall Study
    IV Acetaminophen 1 g/100 mL Solution     IV Placebo 100 mL Solution  
STARTED     166     165  
COMPLETED     154     156  
NOT COMPLETED     12     9  
Adverse Event                 1                 2  
Withdrawal by Subject                 7                 3  
Protocol non-compliance                 2                 2  
Lost to Follow-up                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
IV Acetaminophen 1 g/100 mL Solution All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
IV Placebo 100 mL Solution All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
Total Total of all reporting groups

Baseline Measures
    IV Acetaminophen 1 g/100 mL Solution     IV Placebo 100 mL Solution     Total  
Number of Participants  
[units: participants]
 		  166     165     331  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     163     161     324  
>=65 years     3     4     7  
Gender  
[units: participants]
 		     
Female     166     165     331  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     166     165     331  



  Outcome Measures
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1.  Primary:   Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.   [ Time Frame: Baseline (just prior to the first dose) through 24 hours ]
  Show Outcome Measure 1

2.  Primary:   Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo   [ Time Frame: Baseline (just prior to the first dose) through 48 hours ]
  Show Outcome Measure 2

3.  Secondary:   Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)   [ Time Frame: First dose through 7 day follow up ]
  Show Outcome Measure 3

4.  Secondary:   Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.   [ Time Frame: 32 days following first dose of study medication. ]
  Show Outcome Measure 4


  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 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 text entered.  


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


No publications provided


Responsible Party: Mike Royal, MD, JD, MBA- Vice President Clinical Development-Analgesics, Cadence Pharmaceuticals,Inc.
ClinicalTrials.gov Identifier: NCT00399568     History of Changes
Other Study ID Numbers: CPI-APA-301
Study First Received: November 14, 2006
Results First Received: September 25, 2009
Last Updated: December 9, 2010
Health Authority: United States: Food and Drug Administration