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A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Labopharm Inc.
ClinicalTrials.gov Identifier:
NCT00833794
First received: January 29, 2009
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
Results First Received: April 9, 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
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
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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
1 Tramadol Once A Day No text entered.
2 Placebo No text entered.

Participant Flow for 2 periods

 Period 1:   Open-label Phase
    1 Tramadol Once A Day     2 Placebo  
STARTED     1028 [1]   0 [2]
Entered run-in Period     1027     0  
Received Open-Label Treatment     1023     0  
COMPLETED     646 [3]   0  
NOT COMPLETED     382     0  
Adverse Event                 225                 0  
Lack of Efficacy                 28                 0  
Withdrawal by Subject                 48                 0  
Physician Decision                 20                 0  
Administrative reason                 1                 0  
Protocol Violation                 47                 0  
Did not complete wash-out period                 12                 0  
enrolled in error (immediately D/C)                 1                 0  
[1] Enrolled. Population described in the baseline characteristics is 1023 patients (Open-Label safety).
[2] No Placebo arm during open-label phase.
[3] Randomized in double-blind phase

Period 2:   Double-blind Phase
    1 Tramadol Once A Day     2 Placebo  
STARTED     432 [1]   214 [2]
COMPLETED     326     165  
NOT COMPLETED     106     49  
Adverse Event                 44                 11  
Lack of Efficacy                 34                 22  
Withdrawal by Subject                 23                 6  
Physician Decision                 4                 7  
Administrative reason                 1                 3  
[1] Of the 646 patients who completed the Open-Label phase, 432 were randomized to Tramadol Once A Day
[2] Of the 646 patients who completed the Open-Label phase, 214 were randomized to Placebo



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)   [ Time Frame: 12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment   [ Time Frame: 6 weeks ]
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3.  Secondary:   Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)   [ Time Frame: 12 weeks ]
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4.  Secondary:   WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)   [ Time Frame: 12 weeks ]
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5.  Secondary:   WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)   [ Time Frame: 12 weeks ]
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6.  Secondary:   Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)   [ Time Frame: 12 weeks ]
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7.  Secondary:   Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)   [ Time Frame: week 12 ]
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8.  Secondary:   Time to Response   [ Time Frame: 12 weeks ]
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9.  Secondary:   Discontinuation Due to Lack of Efficacy   [ Time Frame: 12 weeks ]
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10.  Secondary:   Discontinuation Due to Adverse Events   [ Time Frame: 12 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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: NCT00833794     History of Changes
Other Study ID Numbers: MDT3-005
Study First Received: January 29, 2009
Results First Received: April 9, 2009
Last Updated: April 25, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
Romania: National Medicines Agency