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A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.

This study has been completed.
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00613938
First received: January 31, 2008
Last updated: September 23, 2010
Last verified: September 2010
History of Changes
Results First Received: October 2, 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: Arthralgia
Bunion
Hallux Valgus
Pain
Interventions: Drug: Tapentadol (CG5503)
Drug: oxycodone
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
The recruitment period for this inpatient, multicenter study occurred between January 28, 2008 and October 3, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a screening period (duration up to 28 days), and a double blind active treatment period (4 days).

Reporting Groups
  Description
Placebo Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 50mg Fixed Dose Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 75mg Fixed Dose Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
Oxycodone 10mg Fixed Dose Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.

Participant Flow:   Overall Study
    Placebo     Tapentadol 50mg Fixed Dose     Tapentadol 75mg Fixed Dose     Oxycodone 10mg Fixed Dose  
STARTED     69     275     278     279 [1]
COMPLETED     49     247     255     253  
NOT COMPLETED     20     28     23     26  
Withdrawal by Subject                 2                 4                 9                 9  
Adverse Event                 1                 4                 8                 5  
Lack of Efficacy                 16                 18                 5                 9  
Unknown                 1                 2                 1                 3  
[1] one patient did not have a valid baseline score therefore excluded from above



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 50mg Fixed Dose Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 75mg Fixed Dose Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
Oxycodone 10mg Fixed Dose Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
Total Total of all reporting groups

Baseline Measures
    Placebo     Tapentadol 50mg Fixed Dose     Tapentadol 75mg Fixed Dose     Oxycodone 10mg Fixed Dose     Total  
Number of Participants  
[units: participants]
 		  69     275     278     279     901  
Age [1]
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     68     265     268     265     866  
>=65 years     1     10     10     13     34  
Age  
[units: years]
Mean ± Standard Deviation 		  42.8  ± 13.65     42.4  ± 13.23     43.5  ± 12.57     43.4  ± 13.25     43.1  ± 13.05  
Gender [1]
[units: participants]
 		         
Female     64     232     248     233     777  
Male     5     43     30     45     123  
Region of Enrollment [1]
[units: participants]
 		         
United States     69     275     278     278     900  
[1] One patient in the oxycodone 10mg group did not have a valid baseline score and was therefore excluded from the safety analysis set.



  Outcome Measures
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1.  Primary:   Sum of Pain Intensity Difference Over 48 Hours (SPID48)   [ Time Frame: 48 hours ]
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2.  Secondary:   Time to First Rescue Pain Medication Use.   [ Time Frame: 3 days ]
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3.  Secondary:   The SPID at 12 Hours Relative to First Dose.   [ Time Frame: 12 hours ]
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4.  Secondary:   SPID at 24 Hours Relative to First Dose   [ Time Frame: 24 hours ]
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5.  Secondary:   Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3   [ Time Frame: Baseline and 3 days ]
  Show Outcome Measure 5

6.  Secondary:   Total Pain Relief (TOTPAR)at 48 Hours   [ Time Frame: 48 hours ]
  Show Outcome Measure 6


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: Senior Director, Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development
phone: 609-730-4537


No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications automatically indexed to this study:


Responsible Party: Associate Director, Clinical Program Manager, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00613938     History of Changes
Other Study ID Numbers: CR014116, KF5503/38
Study First Received: January 31, 2008
Results First Received: October 2, 2009
Last Updated: September 23, 2010
Health Authority: United States: Food and Drug Administration