A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

This study has been terminated.
(Business decision)
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01063868
First received: February 4, 2010
Last updated: January 30, 2014
Last verified: January 2013
Results First Received: April 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetic Neuropathy, Painful
Diabetic Polyneuropathy
Interventions: Drug: Tapentadol extended release (ER)
Drug: Oxycodone controlled release (CR)

  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
Tapentadol ER Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
Oxycodone CR Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks

Participant Flow:   Overall Study
    Tapentadol ER     Oxycodone CR  
STARTED     35     12  
COMPLETED     0     0  
NOT COMPLETED     35     12  
Adverse Event                 9                 7  
Withdrawal by Subject                 3                 1  
Study Terminated By Sponsor                 23                 4  



  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 ER Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
Oxycodone CR Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
Total Total of all reporting groups

Baseline Measures
    Tapentadol ER     Oxycodone CR     Total  
Number of Participants  
[units: participants]
  35     12     47  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     26     9     35  
>=65 years     9     3     12  
Age  
[units: years]
Mean ± Standard Deviation
  57.5  ± 12.41     60.1  ± 9.23     58.2  ± 11.64  
Gender  
[units: participants]
     
Female     15     2     17  
Male     20     10     30  
Region Enroll (United States of America)  
[units: participants]
  35     12     47  



  Outcome Measures

1.  Primary:   Number of Subjects With Treatment-emergent Adverse Events (TEAE)   [ Time Frame: Entire Study ]


  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
Early termination, due to sponsor's discretion, lead to only 47 patients out of the 800 planned (5.9%) being available for analysis. The data should be interpreted with caution.  


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: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01063868     History of Changes
Other Study ID Numbers: CR016978, R331333PAI3028, KF57
Study First Received: February 4, 2010
Results First Received: April 14, 2011
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration