An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain

This study has been completed.
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00487435
First received: June 14, 2007
Last updated: May 18, 2011
Last verified: April 2011
Results First Received: June 24, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pain
Osteoarthritis
Low Back Pain
Intervention: Drug: Tapentadol (CG5503) Extended Release (ER)

  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 4 June 2007 and 29 June 2009.

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
Tapentadol (CG5503) Extended Release (ER) Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year

Participant Flow:   Overall Study
    Tapentadol (CG5503) Extended Release (ER)  
STARTED     1154 [1]
COMPLETED     669  
NOT COMPLETED     485  
Adverse Event                 146  
Death                 2  
Lack of Efficacy                 33  
Lost to Follow-up                 54  
Pregnancy                 2  
Withdrawal by Subject                 132  
Resolution Of Pain                 1  
Study Medication Non-Compliant                 32  
Unknown                 83  
[1] Patients who received at least one dose of Tapentadol (CG5503) Extended Release (ER)



  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
Tapentadol (CG5503) Extended Release (ER) Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year

Baseline Measures
    Tapentadol (CG5503) Extended Release (ER)  
Number of Participants  
[units: participants]
  1154  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     954  
>=65 years     200  
Age  
[units: years]
Mean ± Standard Deviation
  54.3  ± 11.43  
Gender  
[units: participants]
 
Female     668  
Male     486  
Region Enroll  
[units: participants]
 
Australia     15  
Canada     178  
New Zealand     10  
United States of America     951  



  Outcome Measures
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1.  Primary:   Number of Subjects With Treatment-emergent Adverse Events (TEAE)   [ Time Frame: 52 weeks ]

2.  Secondary:   Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)   [ Time Frame: Baseline, 52 weeks ]


  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 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


Responsible Party: Director, Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00487435     History of Changes
Other Study ID Numbers: CR013567, R331333PAI3010, KF18
Study First Received: June 14, 2007
Results First Received: June 24, 2010
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration