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A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01309386
First received: February 17, 2011
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
Results First Received: February 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasms
Interventions: Drug: Tapentadol ER
Drug: Morphine SR

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tapentadol ER Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
Morphine SR Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.

Participant Flow:   Overall Study
    Tapentadol ER     Morphine SR  
STARTED     50     50  
COMPLETED     28     29  
NOT COMPLETED     22     21  
Unspecified                 2                 0  
Withdrawal by Subject                 2                 0  
Progressive disease                 9                 11  
Physician Decision                 1                 1  
Lack of Efficacy                 3                 1  
Adverse Event                 5                 8  



  Baseline Characteristics
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Reporting Groups
  Description
Tapentadol ER Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
Morphine SR Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
Total Total of all reporting groups

Baseline Measures
    Tapentadol ER     Morphine SR     Total  
Number of Participants  
[units: participants]
 		  50     50     100  
Age, Customized  
[units: Participants]
 		     
Less than 65 years     23     25     48  
More than or equal to 65 years     27     25     52  
Gender  
[units: Participants]
 		     
Female     25     23     48  
Male     25     27     52  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Achieved Pain Control   [ Time Frame: Week 1 ]
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2.  Secondary:   Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8   [ Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy   [ Time Frame: Baseline up to Week 8 ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Patient Global Impression of Change (PGIC)   [ Time Frame: Week 1, 4 and 8 ]
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5.  Secondary:   Total Number of Days of Rescue Medication Over Time   [ Time Frame: Baseline up to Week 8 ]
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6.  Secondary:   Number of Doses of Rescue Medication Over Time   [ Time Frame: Baseline up to Week 8 ]
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7.  Secondary:   Average Change From Baseline in Amount of Rescue Medication Over Time   [ Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 ]
  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 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.


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
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Results Point of Contact:  
Name/Title: Manager
Organization: Neuroscience department, Clinical science department, R&D in Janssen, Chiyodaku, Tokyo 101-0065, Japan
phone: +81-3-4411-5509


No publications provided


Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01309386     History of Changes
Other Study ID Numbers: CR017326, JNS024ER-JPN-C03
Study First Received: February 17, 2011
Results First Received: February 8, 2013
Last Updated: February 8, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency