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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
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
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 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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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 No text entered.
2 Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   1 Tramadol Once A Day   2 Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 432   214   646 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   252   116   368 
>=65 years   180   98   278 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.8  (9.0)   62.3  (8.9)   62.0  (9.0) 
Gender 
[Units: Participants]
     
Female   275   133   408 
Male   157   81   238 


  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 ]

2.  Secondary:   Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment   [ Time Frame: 6 weeks ]

3.  Secondary:   Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)   [ Time Frame: 12 weeks ]

4.  Secondary:   WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)   [ Time Frame: 12 weeks ]

5.  Secondary:   WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)   [ Time Frame: 12 weeks ]

6.  Secondary:   Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)   [ Time Frame: 12 weeks ]

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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Measure Type Secondary
Measure Title Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)
Measure Description This assessment of overall impression of study drug is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)
Time Frame week 12  
Safety Issue No  

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.
Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.

Reporting Groups
  Description
1 Tramadol Once A Day No text entered.
2 Placebo No text entered.

Measured Values
   1 Tramadol Once A Day   2 Placebo 
Participants Analyzed 
[Units: Participants]
 423   210 
Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation) 
[Units: Participants]
   
1 = very much improved   76   25 
2 = much improved   154   71 
3 = minimally improved   108   49 
4 = no change   49   41 
5 = minimally worse   21   17 
6 = much worse   13   5 
7 = very much worse   1   2 
Not determined   1   0 

No statistical analysis provided for Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)



8.  Secondary:   Time to Response   [ Time Frame: 12 weeks ]

9.  Secondary:   Discontinuation Due to Lack of Efficacy   [ Time Frame: 12 weeks ]

10.  Secondary:   Discontinuation Due to Adverse Events   [ 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