Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01038609
First received: December 22, 2009
Last updated: March 10, 2014
Last verified: March 2014
Results First Received: November 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Hydrocodone/Acetaminophen Extended Release
Drug: Acetaminophen
Drug: Morphine Extended Release
Drug: Placebo

  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
No text entered.

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
Acetaminophen 1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
Morphine Extended Release 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Morphine Extended Release / Acetaminophen 1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
Hydrocodone/Acetaminophen Extended Release 1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Placebo 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).

Participant Flow:   Overall Study
    Acetaminophen     Morphine Extended Release     Morphine Extended Release / Acetaminophen     Hydrocodone/Acetaminophen Extended Release     Placebo  
STARTED     50     52     49     48     51  
COMPLETED     49     51     48     47     50  
NOT COMPLETED     1     1     1     1     1  
Adverse Event                 0                 0                 1                 0                 0  
Dosing Error                 0                 0                 0                 1                 1  
Death in the Family                 1                 0                 0                 0                 0  
Refusal of Blood Draws                 0                 1                 0                 0                 0  



  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
Acetaminophen 1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
Morphine Extended Release 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Morphine Extended Release / Acetaminophen 1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
Hydrocodone/Acetaminophen Extended Release 1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Placebo 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Total Total of all reporting groups

Baseline Measures
    Acetaminophen     Morphine Extended Release     Morphine Extended Release / Acetaminophen     Hydrocodone/Acetaminophen Extended Release     Placebo     Total  
Number of Participants  
[units: participants]
  50     52     49     48     51     250  
Age  
[units: years]
Mean ± Standard Deviation
  44.9  ± 13.83     44.0  ± 12.93     40.2  ± 11.31     40.4  ± 13.16     45.2  ± 12.47     43.0  ± 12.85  
Gender  
[units: participants]
           
Female     45     44     39     41     45     214  
Male     5     8     10     7     6     36  



  Outcome Measures
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1.  Primary:   Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue Scale (VAS)   [ Time Frame: From time of first study drug administration to 48 hours following first study drug administration ]

2.  Secondary:   TOTPAR (Total Pain Relief)   [ Time Frame: From time of first study drug administration to 48 hours following first study drug administration ]

3.  Secondary:   Participant's Global Assessment of Study Drug   [ Time Frame: From time of first study drug administration to 48 hours following first study drug administration ]

4.  Secondary:   Time to Perceptible and Meaningful Pain Relief   [ Time Frame: From time of first study drug administration to 12 hours following first study drug administration ]

5.  Secondary:   Participants With Adverse Events (AEs)   [ Time Frame: AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 32 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days). ]

6.  Secondary:   Number of Participants With Vital Signs Values Meeting Potentially Clinically Significant Criteria   [ Time Frame: At specified intervals from Screening through 7 days after first dose of study drug ]

7.  Secondary:   Number of Participants With Chemistry Values Meeting Potentially Clinically Significant Criteria   [ Time Frame: At specified intervals from Screening through 7 days after first dose of study drug ]


  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: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01038609     History of Changes
Other Study ID Numbers: M12-058
Study First Received: December 22, 2009
Results First Received: November 1, 2013
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration