An Open-Label Long-term Safety Study of Tramadol HCl OAD (Once A Day) 300 mg in the Treatment of Pain Due to Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Labopharm Inc.
ClinicalTrials.gov Identifier:
NCT00833911
First received: January 29, 2009
Last updated: April 25, 2012
Last verified: April 2012
Results First Received: April 8, 2009  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoarthritis, Knee
Intervention: Drug: Tramadol Once A Day

  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
300 mg Tramadol HCl OAD No text entered.

Participant Flow for 3 periods

Period 1:   Titration
    300 mg Tramadol HCl OAD  
STARTED     392  
COMPLETED     371  
NOT COMPLETED     21  
Adverse Event                 18  
Withdrawal by Subject                 3  

Period 2:   Maintenance Phase I
    300 mg Tramadol HCl OAD  
STARTED     371  
COMPLETED     273  
NOT COMPLETED     98  
Adverse Event                 73  
Withdrawal by Subject                 11  
Physician Decision                 10  
Lack of Efficacy                 4  

Period 3:   Maintenance Phase II
    300 mg Tramadol HCl OAD  
STARTED     176 [1]
COMPLETED     166  
NOT COMPLETED     10  
Adverse Event                 6  
Physician Decision                 2  
Withdrawal by Subject                 1  
Lack of Efficacy                 1  
[1] 97 patients chose not to continue into Maintenance Phase II



  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
300 mg Tramadol HCl OAD No text entered.

Baseline Measures
    300 mg Tramadol HCl OAD  
Number of Participants  
[units: participants]
  392  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     229  
>=65 years     163  
Age  
[units: years]
Mean ± Standard Deviation
  61.4  ± 8.5  
Gender  
[units: participants]
 
Female     333  
Male     59  



  Outcome Measures

1.  Primary:   Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation   [ Time Frame: 6 months and 12 months ]


  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 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: Director of Regulatory Affairs
Organization: Labopharm Inc.
phone: 1 450 686 1017


Publications of Results:

Responsible Party: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00833911     History of Changes
Other Study ID Numbers: MDT3-004
Study First Received: January 29, 2009
Results First Received: April 8, 2009
Last Updated: April 25, 2012
Health Authority: Romania: National Medicines Agency