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A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00736957
First received: August 14, 2008
Last updated: June 23, 2014
Last verified: June 2014
Results First Received: March 25, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Pain
Intervention: Drug: Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)

  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
219 participants were enrolled in this study out of which 29 participants did not meet the criteria to transfer to treatment period 1.

Reporting Groups
  Description
Tramadol Hydrochloride Plus Acetaminophen (JNS013) Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.

Participant Flow:   Overall Study
    Tramadol Hydrochloride Plus Acetaminophen (JNS013)  
STARTED     219  
Treated     190  
COMPLETED     97  
NOT COMPLETED     122  
Adverse Event                 43  
Withdrawal by Subject                 49  
violation of eligibility criteria                 2  
did not attend hospital appointments                 1  
not eligible for Treatment Period I                 22  
Physician Decision                 5  



  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
Tramadol Hydrochloride Plus Acetaminophen (JNS013) Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.

Baseline Measures
    Tramadol Hydrochloride Plus Acetaminophen (JNS013)  
Number of Participants  
[units: participants]
  190  
Age [1]
[units: years]
Mean ± Standard Deviation
  64.3  ± 12.9  
Gender [1]
[units: participants]
 
Female     106  
Male     84  
[1] Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.



  Outcome Measures
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1.  Primary:   Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4   [ Time Frame: Baseline and Week 4 ]

2.  Primary:   Change From Baseline in VAS24 Score at Week 52   [ Time Frame: Baseline and Week 52 ]

3.  Secondary:   Number of Participants With Improvement From Baseline in VAS24 Score   [ Time Frame: Week 4 and 52 ]

4.  Secondary:   Pain Intensity Difference (PID) at Week 4   [ Time Frame: Week 4 ]

5.  Secondary:   Pain Relief (PAR) Score at Week 4   [ Time Frame: Week 4 ]

6.  Secondary:   Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4   [ Time Frame: Week 4 ]

7.  Secondary:   Change From Baseline in Short Form-36 (SF-36) Score   [ Time Frame: Baseline, Week 4 and 52 ]


  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: Medical Director
Organization: Neuroscience Department, Clinical Science Division, R&D, JANSSEN PHARMACEUTICAL. K.K. 5-2, Nishi-kanda 3-chome, Cyiyoda-ku, Tokyo 101-0065 JAPAN
phone: +81-3-4411-5509


No publications provided


Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00736957     History of Changes
Other Study ID Numbers: CR015115, JNS013-JPN-05
Study First Received: August 14, 2008
Results First Received: March 25, 2013
Last Updated: June 23, 2014
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center
Japan: Pharmaceuticals and Medical Devices Agency