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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:
ClinicalTrials.gov Identifier:
NCT00832416
First Posted: January 30, 2009
Last Update Posted: April 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Labopharm Inc.
Results First Submitted: April 8, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
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.

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 
Overall Participants Analyzed 
[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


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



Responsible Party: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00832416     History of Changes
Other Study ID Numbers: MDT3-002
First Submitted: January 29, 2009
First Posted: January 30, 2009
Results First Submitted: April 8, 2009
Results First Posted: August 3, 2009
Last Update Posted: April 30, 2012