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A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00950651
First Posted: August 3, 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 14, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Osteoarthritis, Knee
Pain
Interventions: Drug: Tramadol HCl Contramid® Once A Day
Drug: Tramadol HCl Twice 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
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
Tramadol HCl Contramid® Once A Day The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
Tramadol HCl Twice a Day (SR) The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.

Participant Flow:   Overall Study
    Tramadol HCl Contramid® Once A Day   Tramadol HCl Twice a Day (SR)
STARTED   215   216 [1] 
COMPLETED   184   181 
NOT COMPLETED   31   35 
Adverse Event                17                20 
Death                1                0 
Lack of Efficacy                2                2 
Protocol Violation                3                4 
Withdrawal by Subject                8                9 
[1] 216 patients randomized but one never took study medication



  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 HCl Contramid® Once A Day The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
Tramadol HCl Twice a Day (SR) The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
Total Total of all reporting groups

Baseline Measures
   Tramadol HCl Contramid® Once A Day   Tramadol HCl Twice a Day (SR)   Total 
Overall Participants Analyzed 
[Units: Participants]
 215   215   430 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   121   137   258 
>=65 years   94   78   172 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.9  (8.8)   59.9  (9.1)   60.9  (9.0) 
Gender 
[Units: Participants]
     
Female   181   176   357 
Male   34   39   73 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12   [ Time Frame: Baseline to week 12 ]

2.  Secondary:   Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)   [ Time Frame: 12 weeks ]

3.  Secondary:   Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12   [ Time Frame: Baseline to week 12 ]

4.  Secondary:   Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12   [ Time Frame: Baseline to week 12 ]

5.  Secondary:   Percentage of Change From Baseline in WOMAC Total Score at Week 12   [ Time Frame: Baseline to week 12 ]

6.  Secondary:   Percentage of Change From Baseline in Current Pain at Week 12   [ Time Frame: Baseline to week 12 ]

7.  Secondary:   Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12   [ Time Frame: Baseline to week 12 ]

8.  Secondary:   Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12   [ Time Frame: Baseline to week 12 ]

9.  Secondary:   Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12   [ Time Frame: Baseline to week 12 ]

10.  Secondary:   Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12   [ Time Frame: Baseline to week 12 ]

11.  Secondary:   Patient Global Rating of Pain Relief at Week 12   [ Time Frame: 12 Weeks ]

12.  Secondary:   Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12   [ Time Frame: 12 weeks ]

13.  Secondary:   Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12   [ Time Frame: 12 weeks ]

14.  Secondary:   Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12   [ Time Frame: 12 weeks ]

15.  Secondary:   Physician Overall Rating: Overall Assessment at Week 12   [ Time Frame: 12 weeks ]

16.  Secondary:   Physician Overall Rating: Effectiveness of Pain Control 24 Hours After the Most Recent Dose of Tramadol at Week 12   [ Time Frame: 12 weeks ]

17.  Secondary:   Patient Diary: Pain (Between Visit Means) at Week 12   [ Time Frame: 12 weeks ]

18.  Secondary:   Patient Diary: Stiffness (Between Visit Means) at Week 12   [ Time Frame: 12 weeks ]

19.  Secondary:   Patient Diary: Ability Getting Things Done (Between Visit Means) at Week 12   [ Time Frame: 12 weeks ]

20.  Secondary:   Patient Diary: Difficulty With Walking (Between Visit Means) at Week 12   [ Time Frame: 12 weeks ]

21.  Secondary:   Patient Diary: Difficulty With Stairs (Between Visit Means) at Week 12   [ 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


Publications of Results:

Responsible Party: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00950651     History of Changes
Other Study ID Numbers: MDT3-001-E1
First Submitted: April 14, 2009
First Posted: August 3, 2009
Results First Submitted: April 14, 2009
Results First Posted: August 3, 2009
Last Update Posted: April 30, 2012