Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 98 of 458 for:    TRAMADOL

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

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.
 
ClinicalTrials.gov Identifier: NCT00950651
Recruitment Status : Completed
First Posted : August 3, 2009
Results First Posted : August 3, 2009
Last Update Posted : April 30, 2012
Sponsor:
Information provided by (Responsible Party):
Labopharm Inc.

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
Enrollment 431
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 215 216 [1]
Completed 184 181
Not Completed 31 35
Reason Not Completed
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
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 215 215 430
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants 215 participants 430 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
121
  56.3%
137
  63.7%
258
  60.0%
>=65 years
94
  43.7%
78
  36.3%
172
  40.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 215 participants 215 participants 430 participants
61.9  (8.8) 59.9  (9.1) 60.9  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants 215 participants 430 participants
Female
181
  84.2%
176
  81.9%
357
  83.0%
Male
34
  15.8%
39
  18.1%
73
  17.0%
1.Primary Outcome
Title Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12
Hide Description The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. The Pain subscale score consists of 5 items each rated on a 100mm VAS scale (0mm=no pain to 100mm=extreme pain). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: percentage of change
58.3  (29.9) 58.7  (27.0)
2.Secondary Outcome
Title Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)
Hide Description Each day before morning dose, patients assessed arthritis pain in worst knee in a diary using a 5-point rating scale ranging from none to severe. A median score was estimated for each patient each week and re-categorized into different degrees of pain (rounding off to the closest integer). Results are of 12th week (day 78-84).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Measure Type: Number
Unit of Measure: participants
None 20 19
Barely noticeable 42 33
Mild 35 40
Moderate 35 32
Severe 2 5
3.Secondary Outcome
Title Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12
Hide Description The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Stiffness subscale score consists of 2 items each rated on 100mm VAS scale (0mm=no stiffness to 100mm=extreme stiffness). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: percentage of change
49.1  (60.8) 49.5  (37.9)
4.Secondary Outcome
Title Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12
Hide Description The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Physical Function subscale score consists of 17 items rated on a 100mm VAS scale (0mm=no difficulty to 100mm=extreme difficulty). In case of premature discontinuation, the last assessment was used to calculate percentage of change
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: percentage of change
50.8  (32.5) 49.8  (29.7)
5.Secondary Outcome
Title Percentage of Change From Baseline in WOMAC Total Score at Week 12
Hide Description The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Each item is rated on a 100mm VAS scale (0mm=no pain/stiffness/difficulty to 100mm=extreme no pain/stiffness/difficulty). In case of premature discontinuation, the last assessment was used to calculate percentage of change.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: percentage of change
52.9  (30.9) 52.0  (28.5)
6.Secondary Outcome
Title Percentage of Change From Baseline in Current Pain at Week 12
Hide Description Pain Visual Analogue Scales: Current Pain. Patients indicated their current pain using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change in current pain was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: percentage of change
35.1  (23.8) 34.6  (23.5)
7.Secondary Outcome
Title Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12
Hide Description Patients indicated their Least Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: percentage of change
21.6  (21.3) 23.5  (21.2)
8.Secondary Outcome
Title Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12
Hide Description Patients indicated their Worst Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: percentage of change
38.6  (27.9) 39.2  (26.3)
9.Secondary Outcome
Title Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12
Hide Description Patients indicated their Average Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: percentage of change
30.1  (22.0) 30.7  (19.7)
10.Secondary Outcome
Title Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12
Hide Description The walking test is a measure of how many seconds it takes the patient to walk a distance of 15 meters. The change from baseline to week 12 was calculated.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: percentage of change
5.639  (6.231) 4.738  (5.495)
11.Secondary Outcome
Title Patient Global Rating of Pain Relief at Week 12
Hide Description The Patient Global Rating of Pain is a Likert-scale that answers the question: "How do you rate overall pain relief with the drug?" with 4 possible answers that were dichotomized: "very effective", "effective", and "somewhat effective" were summarized to “effective”; “not effective” remained unchanged.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Measure Type: Number
Unit of Measure: participants
Effective 160 151
Not effective 1 2
12.Secondary Outcome
Title Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12
Hide Description Patients were asked: “How have any side effects you may have felt from the drug interfered with day-to-day activities?” with 4 possible answers: “Significantly”, “Somewhat”, “Minimally”, “Not at all”.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Measure Type: Number
Unit of Measure: participants
Significantly 7 2
Somewhat 15 18
Minimally 39 34
Not at all 100 99
13.Secondary Outcome
Title Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12
Hide Description Patients who have previously taken tramadol HCl were asked to compare how they compare the current pain relief to the pain relief felt when previously taking tramadol, using a 4-point Likert-scale: "Worse than before", "Same as before", "Somewhat better now", or “Much better now”.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Measure Type: Number
Unit of Measure: participants
Worse than before 0 0
Same as before 4 2
Somewhat better now 11 3
Much better now 8 8
14.Secondary Outcome
Title Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12
Hide Description Patients who have previously taken tramadol HCl were asked: “Compared to when you were previously taking tramadol, how have any side effects you have felt during this study interfered with your day-to-day activities?”. Possible answers were: “Interfered much less now”, “Interfered somewhat less now”, “Same as before”, “Interfered more now”.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Measure Type: Number
Unit of Measure: participants
Interfered much less now 4 8
Interfered somewhat less now 2 1
Same as before 13 4
Interfered more now 3 0
15.Secondary Outcome
Title Physician Overall Rating: Overall Assessment at Week 12
Hide Description The physician was asked to indicate his overall assessment of the formulation the patient was taking using a 4-point Likert-scale dichotomized for the analysis: Very Effective, Effective, and Somewhat Effective were summarized to Effective; Ineffective remained unchanged.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Measure Type: Number
Unit of Measure: participants
Effective 160 150
Not effective 1 3
16.Secondary Outcome
Title Physician Overall Rating: Effectiveness of Pain Control 24 Hours After the Most Recent Dose of Tramadol at Week 12
Hide Description The physician was asked to indicate the effectiveness of pain control 24 hours after the most recent dose of tramadol using a 4-point Likert-scale, dichotomized for the analysis: Very Effective, Effective, Somewhat Effective were summarized to Effective; Ineffective remained unchanged.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Measure Type: Number
Unit of Measure: participants
Effective 160 151
Not effective 1 2
17.Secondary Outcome
Title Patient Diary: Pain (Between Visit Means) at Week 12
Hide Description As part of the daily diary for the entire study, patients rated the arthritis pain in their worst knee using a five-point scale ranging from 1=none to 5=severe. Mean scores summarizing the entries of the preceding period were calculated.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.74  (0.98) 2.86  (1.08)
18.Secondary Outcome
Title Patient Diary: Stiffness (Between Visit Means) at Week 12
Hide Description As part of the daily diary for the entire study, patients rated the stiffness in their worst knee using a five-point scale ranging from 1=none to 5=severe. Mean scores summarizing the entries of the preceding period were calculated.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.67  (0.96) 2.82  (1.06)
19.Secondary Outcome
Title Patient Diary: Ability Getting Things Done (Between Visit Means) at Week 12
Hide Description As part of the daily diary for the entire study, patients rated their ability to get things done with their worst knee using a five-point scale ranging from: 1=No problem to 5=A lot of things didn’t get done. Mean scores summarizing the entries of the preceding period were calculated.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.41  (1.14) 2.34  (1.18)
20.Secondary Outcome
Title Patient Diary: Difficulty With Walking (Between Visit Means) at Week 12
Hide Description As part of the daily diary for the entire study, patients rated their difficulty walking with their worst knee using a five-point scale ranging from 1=No problem to 5=Severe difficulty. Mean scores summarizing the entries of the preceding period were calculated.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.79  (1.05) 2.85  (1.11)
21.Secondary Outcome
Title Patient Diary: Difficulty With Stairs (Between Visit Means) at Week 12
Hide Description As part of the daily diary for the entire study, patients rated their difficulty with stairs with their worst knee using a five-point scale ranging from 1=No problem to 5=Severe difficulty. Mean scores summarizing the entries of the preceding period were calculated.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 153
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.97  (1.14) 3.10  (1.16)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/215 (1.40%)      8/215 (3.72%)    
Cardiac disorders     
Angina Unstable *  0/215 (0.00%)  0 1/215 (0.47%)  1
Coronary Artery Insufficiency *  1/215 (0.47%)  1 0/215 (0.00%)  0
Gastrointestinal disorders     
Peritoneal Adhesions *  0/215 (0.00%)  0 1/215 (0.47%)  1
General disorders     
Chest Pain *  0/215 (0.00%)  0 1/215 (0.47%)  1
Hepatobiliary disorders     
Cholelithiasis *  0/215 (0.00%)  0 1/215 (0.47%)  1
Injury, poisoning and procedural complications     
Tibia Fracture *  0/215 (0.00%)  0 1/215 (0.47%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder Neoplasm NOS *  0/215 (0.00%)  0 1/215 (0.47%)  1
Nervous system disorders     
Cerebrovascular Disorder NOS *  0/215 (0.00%)  0 1/215 (0.47%)  1
Ischaemic Stroke NOS *  1/215 (0.47%)  1 0/215 (0.00%)  0
Renal and urinary disorders     
Renal Colic *  0/215 (0.00%)  0 1/215 (0.47%)  1
Vascular disorders     
Essential Hypertension *  1/215 (0.47%)  1 0/215 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tramadol HCl Contramid® Once A Day Tramadol HCl Twice a Day (SR)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   159/215 (73.95%)      159/215 (73.95%)    
Gastrointestinal disorders     
Constipation *  73/215 (33.95%)  136 65/215 (30.23%)  143
Dry mouth *  20/215 (9.30%)  28 10/215 (4.65%)  15
Nausea *  70/215 (32.56%)  121 73/215 (33.95%)  134
Vomiting *  18/215 (8.37%)  24 31/215 (14.42%)  34
General disorders     
Weakness *  24/215 (11.16%)  33 31/215 (14.42%)  47
Nervous system disorders     
Dizziness *  51/215 (23.72%)  85 65/215 (30.23%)  97
Headache *  27/215 (12.56%)  37 38/215 (17.67%)  54
Somnolence *  65/215 (30.23%)  113 46/215 (21.40%)  67
Skin and subcutaneous tissue disorders     
Sweating increased *  16/215 (7.44%)  17 15/215 (6.98%)  25
*
Indicates events were collected by non-systematic assessment
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.
Prior to submitting results communications, the investigator shall allow Labopharm at least 30 days to review the proposed communication. If the proposed publication/disclosure risks Labopharm's ability to patent any invention related to the study, the publication or disclosure will be modified or delayed to allow Labopharm to seek patent protection. This statement does not give Labopharm any editorial rights other than to restrict the disclosure of Labopharm's confidential information
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Regulatory Affairs
Organization: Labopharm Inc.
Phone: 1 450 686 1017
Layout table for additonal information
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