Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Show All Outcome Measures

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 ]
  Hide Outcome Measure 6

Measure Type Secondary
Measure Title Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)
Measure Description This assessment of overall status integrates the effect of the treatment on pain, side effects, and the patient's expectation of pain relief. It 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 12 weeks  
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  
Number of Participants Analyzed  
[units: participants]
  425     210  
Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)  
[units: participants]
   
1 = very much improved     86     27  
2 = much improved     148     59  
3 = minimally improved     108     58  
4 = no change     49     42  
5 = minimally worse     17     13  
6 = much worse     17     8  
7 = very much worse     0     3  

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



7.  Secondary:   Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)   [ Time Frame: week 12 ]

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
  Hide 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.


  More Information