A Four-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol Once a Day 100, 200 and 300 mg Versus Placebo for 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:
NCT00832416
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: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Pain
Osteoarthritis, Knee
Interventions: Drug: Tramadol Once A Day
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
No text entered.

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
1: Tramadol Once A Day 100mg No text entered.
2: Tramadol Once A Day 200mg No text entered.
3: Tramadol Once A Day 300mg No text entered.
4: Placebo No text entered.

Participant Flow:   Overall Study
    1: Tramadol Once A Day 100mg     2: Tramadol Once A Day 200mg     3: Tramadol Once A Day 300mg     4: Placebo  
STARTED     110     113     115     227  
COMPLETED     64     60     54     144  
NOT COMPLETED     46     53     61     83  
Lack of Efficacy                 17                 15                 13                 52  
Withdrawal by Subject                 5                 7                 2                 10  
Physician Decision                 2                 12                 5                 10  
Administrative                 0                 0                 0                 1  
Adverse Event                 21                 19                 41                 10  
Death                 1                 0                 0                 0  



  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
1: Tramadol Once A Day 100mg No text entered.
2: Tramadol Once A Day 200mg No text entered.
3: Tramadol Once A Day 300mg No text entered.
4: Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    1: Tramadol Once A Day 100mg     2: Tramadol Once A Day 200mg     3: Tramadol Once A Day 300mg     4: Placebo     Total  
Number of Participants  
[units: participants]
  110     113     115     227     565  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     69     77     66     139     351  
>=65 years     41     36     49     88     214  
Age  
[units: years]
Mean ± Standard Deviation
  59.8  ± 9.0     59.8  ± 8.4     61.0  ± 9.6     60.6  ± 9.6     60.4  ± 9.3  
Gender  
[units: participants]
         
Female     65     64     72     140     341  
Male     45     49     43     87     224  



  Outcome Measures
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1.  Primary:   Patient Global Rating of Pain for the Study Period (12 Weeks)   [ Time Frame: 12 weeks ]

2.  Primary:   Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)   [ Time Frame: Baseline to week 12 ]

3.  Primary:   Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)   [ Time Frame: Baseline to week 12 ]

4.  Secondary:   Percentage Difference in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)   [ Time Frame: Week 0, week 3, week 6 ]

5.  Secondary:   Percentage Difference in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)   [ Time Frame: Week 0, week 3, week 6 ]

6.  Secondary:   Multiple Dose Effect Using 24-hour VAS Pain Questionnaire   [ Time Frame: 12 weeks ]

7.  Secondary:   Investigator Global Rating of Pain Relief   [ Time Frame: 12 weeks ]

8.  Secondary:   Percentage of Participants Who Dropped Out From Trial by Dropout Reason   [ Time Frame: 12 weeks ]


  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
No text entered.  


Results Point of Contact:  
Name/Title: Director of Regulatory Affairs
Organization: Labopharm Inc.
phone: 1 450 686 1017


No publications provided


Responsible Party: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00832416     History of Changes
Other Study ID Numbers: MDT3-002
Study First Received: January 29, 2009
Results First Received: April 8, 2009
Last Updated: April 25, 2012
Health Authority: United States: Food and Drug Administration