A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01124617
First received: April 22, 2010
Last updated: December 11, 2013
Last verified: December 2013
Results First Received: March 27, 2013  
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: Pain
Diabetic Neuropathies
Neuralgia
Postherpetic Neuralgia
Interventions: Drug: Tapentadol
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
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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 Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
Placebo Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.

Participant Flow:   Overall Study
    Tapentadol     Placebo  
STARTED     60     31  
COMPLETED     41     25  
NOT COMPLETED     19     6  
Adverse Event                 5                 2  
Lack of Efficacy                 2                 1  
Protocol Violation                 1                 1  
Withdrawal by Subject                 9                 1  
Unspecified                 2                 1  



  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.
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Reporting Groups
  Description
Tapentadol Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
Placebo Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Tapentadol     Placebo     Total  
Number of Participants  
[units: participants]
  60     31     91  
Age  
[units: Years]
Mean ± Standard Deviation
  64.6  ± 12.98     68.6  ± 11.60     65.9  ± 12.61  
Gender  
[units: Participants]
     
Female     26     14     40  
Male     34     17     51  



  Outcome Measures
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1.  Primary:   Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11   [ Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 ]

3.  Secondary:   Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS)   [ Time Frame: Week 12 ]

4.  Secondary:   Number of Participants With Categorical Scores on Patient’s Global Impression of Change (PGIC) Scale   [ Time Frame: Week 8 and Week 12 ]

5.  Secondary:   Number of Participants With Categorical Scores on Physician’s Global Assessment Scale   [ Time Frame: Week 8 and Week 12 ]

6.  Secondary:   Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12   [ Time Frame: Baseline and Week 12 ]

10.  Secondary:   Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12   [ Time Frame: Baseline and Week 12 ]

11.  Secondary:   Number of Participants With Awakenings Based on Sleep Questionnaire   [ Time Frame: Baseline and Week 12 ]

12.  Secondary:   Number of Participants With Response Based on Overall Quality of Sleep Questionnaire   [ Time Frame: Baseline and Week 12 ]

13.  Secondary:   Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12   [ Time Frame: Baseline and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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


No publications provided


Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01124617     History of Changes
Other Study ID Numbers: CR017002, JNS024ER-JPN-N22
Study First Received: April 22, 2010
Results First Received: March 27, 2013
Last Updated: December 11, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency