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Tapentadol (CG5503)

This study has been completed.
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00421928
First received: January 12, 2007
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
Results First Received: July 8, 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: Osteoarthritis, Knee
Pain
Interventions: Drug: oxycodone
Drug: placebo
Drug: tapentadol (CG5503)

  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 out-patient, multicenter study occurred between 07 February 2007 and 15 July 08.

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 14 days), a washout period (duration 3 to 7 days), a double-blind active treatment period with titration period (duration 3 weeks) and maintenance period (duration 12 weeks)

Reporting Groups
  Description
Tapentadol (CG5503) Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
Oxycodone oxycodone controlled release (CR)20-50mg twice daily (BID)
Placebo Matching Placebo twice daily (BID)

Participant Flow:   Overall Study
    Tapentadol (CG5503)     Oxycodone     Placebo  
STARTED     344 [1]   342 [2]   337 [1]
COMPLETED     181     118     203  
NOT COMPLETED     163     224     134  
Adverse Event                 61                 140                 22  
Lost to Follow-up                 5                 0                 3  
Withdrawal by Subject                 50                 48                 43  
Lack of Efficacy                 15                 7                 35  
Study drug non-compliant                 6                 7                 4  
All other                 26                 21                 27  
Death                 0                 1                 0  
[1] 2 randomly assigned to this treatment group did not receive drug
[2] 2 randomly assigned to this treatment group did not receive drug. One subject was enrolled twice.



  Baseline Characteristics
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Reporting Groups
  Description
Tapentadol (CG5503) Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
Oxycodone oxycodone controlled release (CR)20-50mg twice daily (BID)
Placebo Matching Placebo twice daily (BID)
Total Total of all reporting groups

Baseline Measures
    Tapentadol (CG5503)     Oxycodone     Placebo     Total  
Number of Participants  
[units: participants]
 		  344     342     337     1023  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     249     249     260     758  
>=65 years     95     93     77     265  
Age  
[units: years]
Mean ± Standard Deviation 		  58.4  ± 10.09     58.2  ± 10.29     58.2  ± 9.15     58.3  ± 9.85  
Gender  
[units: participants]
 		       
Female     216     202     200     618  
Male     128     140     137     405  



  Outcome Measures
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1.  Primary:   Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.   [ Time Frame: Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period). ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12   [ Time Frame: Baseline and 12 week endpoint ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.   [ Time Frame: Baseline and 12 week endpoint ]
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4.  Secondary:   Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12   [ Time Frame: Baseline and 12 week endpoint ]
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5.  Secondary:   Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy   [ Time Frame: Baseline to 12 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12   [ Time Frame: Baseline and 12 week endpoint ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Responder Analysis 50% Improvement to Week 12   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 7


  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 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.
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, L.L.C.
phone: 609-730-4537


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

Publications automatically indexed to this study:


Responsible Party: Director, Clinical Leader, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00421928     History of Changes
Other Study ID Numbers: CR013402, R331333PAI3008, KF11
Study First Received: January 12, 2007
Results First Received: July 8, 2009
Last Updated: April 16, 2012
Health Authority: United States: Food and Drug Administration