Trial Outcomes & Findings for 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 (NCT NCT00950651)
NCT ID: NCT00950651
Last Updated: 2012-04-30
Results Overview
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.
COMPLETED
PHASE3
431 participants
Baseline to week 12
2012-04-30
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
215
|
216
|
|
Overall Study
COMPLETED
|
184
|
181
|
|
Overall Study
NOT COMPLETED
|
31
|
35
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
17
|
20
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Protocol Violation
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
8
|
9
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Tramadol HCl Contramid® Once A Day
n=215 Participants
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)
n=215 Participants
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
n=430 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
121 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
94 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Age Continuous
|
61.9 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
181 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
357 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12
|
58.3 percentage of change
Standard Deviation 29.9
|
58.7 percentage of change
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)
None
|
20 participants
|
19 participants
|
|
Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)
Barely noticeable
|
42 participants
|
33 participants
|
|
Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)
Mild
|
35 participants
|
40 participants
|
|
Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)
Moderate
|
35 participants
|
32 participants
|
|
Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)
Severe
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12
|
49.1 percentage of change
Standard Deviation 60.8
|
49.5 percentage of change
Standard Deviation 37.9
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: 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.
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
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12
|
50.8 percentage of change
Standard Deviation 32.5
|
49.8 percentage of change
Standard Deviation 29.7
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Percentage of Change From Baseline in WOMAC Total Score at Week 12
|
52.9 percentage of change
Standard Deviation 30.9
|
52.0 percentage of change
Standard Deviation 28.5
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Percentage of Change From Baseline in Current Pain at Week 12
|
35.1 percentage of change
Standard Deviation 23.8
|
34.6 percentage of change
Standard Deviation 23.5
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12
|
21.6 percentage of change
Standard Deviation 21.3
|
23.5 percentage of change
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12
|
38.6 percentage of change
Standard Deviation 27.9
|
39.2 percentage of change
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12
|
30.1 percentage of change
Standard Deviation 22.0
|
30.7 percentage of change
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12
|
5.639 percentage of change
Standard Deviation 6.231
|
4.738 percentage of change
Standard Deviation 5.495
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Patient Global Rating of Pain Relief at Week 12
Effective
|
160 participants
|
151 participants
|
|
Patient Global Rating of Pain Relief at Week 12
Not effective
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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".
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12
Significantly
|
7 participants
|
2 participants
|
|
Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12
Somewhat
|
15 participants
|
18 participants
|
|
Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12
Minimally
|
39 participants
|
34 participants
|
|
Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12
Not at all
|
100 participants
|
99 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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".
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12
Worse than before
|
0 participants
|
0 participants
|
|
Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12
Same as before
|
4 participants
|
2 participants
|
|
Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12
Somewhat better now
|
11 participants
|
3 participants
|
|
Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12
Much better now
|
8 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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".
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12
Interfered much less now
|
4 participants
|
8 participants
|
|
Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12
Interfered somewhat less now
|
2 participants
|
1 participants
|
|
Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12
Same as before
|
13 participants
|
4 participants
|
|
Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12
Interfered more now
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Physician Overall Rating: Overall Assessment at Week 12
Effective
|
160 participants
|
150 participants
|
|
Physician Overall Rating: Overall Assessment at Week 12
Not effective
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Physician Overall Rating: Effectiveness of Pain Control 24 Hours After the Most Recent Dose of Tramadol at Week 12
Effective
|
160 participants
|
151 participants
|
|
Physician Overall Rating: Effectiveness of Pain Control 24 Hours After the Most Recent Dose of Tramadol at Week 12
Not effective
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Patient Diary: Pain (Between Visit Means) at Week 12
|
2.74 Units on a scale
Standard Deviation 0.98
|
2.86 Units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Patient Diary: Stiffness (Between Visit Means) at Week 12
|
2.67 Units on a scale
Standard Deviation 0.96
|
2.82 Units on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Patient Diary: Ability Getting Things Done (Between Visit Means) at Week 12
|
2.41 Units on a scale
Standard Deviation 1.14
|
2.34 Units on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Patient Diary: Difficulty With Walking (Between Visit Means) at Week 12
|
2.79 Units on a scale
Standard Deviation 1.05
|
2.85 Units on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Tramadol HCl Contramid® Once A Day
n=161 Participants
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)
n=153 Participants
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.
|
|---|---|---|
|
Patient Diary: Difficulty With Stairs (Between Visit Means) at Week 12
|
2.97 Units on a scale
Standard Deviation 1.14
|
3.10 Units on a scale
Standard Deviation 1.16
|
Adverse Events
Tramadol HCl Contramid® Once A Day
Tramadol HCl Twice a Day (SR)
Serious adverse events
| Measure |
Tramadol HCl Contramid® Once A Day
n=215 participants at risk
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)
n=215 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/215
|
0.47%
1/215 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm NOS
|
0.00%
0/215
|
0.47%
1/215 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular Disorder NOS
|
0.00%
0/215
|
0.47%
1/215 • Number of events 1
|
|
General disorders
Chest Pain
|
0.00%
0/215
|
0.47%
1/215 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/215
|
0.47%
1/215 • Number of events 1
|
|
Cardiac disorders
Coronary Artery Insufficiency
|
0.47%
1/215 • Number of events 1
|
0.00%
0/215
|
|
Vascular disorders
Essential Hypertension
|
0.47%
1/215 • Number of events 1
|
0.00%
0/215
|
|
Nervous system disorders
Ischaemic Stroke NOS
|
0.47%
1/215 • Number of events 1
|
0.00%
0/215
|
|
Gastrointestinal disorders
Peritoneal Adhesions
|
0.00%
0/215
|
0.47%
1/215 • Number of events 1
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/215
|
0.47%
1/215 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/215
|
0.47%
1/215 • Number of events 1
|
Other adverse events
| Measure |
Tramadol HCl Contramid® Once A Day
n=215 participants at risk
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)
n=215 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
34.0%
73/215 • Number of events 136
|
30.2%
65/215 • Number of events 143
|
|
Nervous system disorders
Dizziness
|
23.7%
51/215 • Number of events 85
|
30.2%
65/215 • Number of events 97
|
|
Gastrointestinal disorders
Dry mouth
|
9.3%
20/215 • Number of events 28
|
4.7%
10/215 • Number of events 15
|
|
Nervous system disorders
Headache
|
12.6%
27/215 • Number of events 37
|
17.7%
38/215 • Number of events 54
|
|
Gastrointestinal disorders
Nausea
|
32.6%
70/215 • Number of events 121
|
34.0%
73/215 • Number of events 134
|
|
Nervous system disorders
Somnolence
|
30.2%
65/215 • Number of events 113
|
21.4%
46/215 • Number of events 67
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
7.4%
16/215 • Number of events 17
|
7.0%
15/215 • Number of events 25
|
|
Gastrointestinal disorders
Vomiting
|
8.4%
18/215 • Number of events 24
|
14.4%
31/215 • Number of events 34
|
|
General disorders
Weakness
|
11.2%
24/215 • Number of events 33
|
14.4%
31/215 • Number of events 47
|
Additional Information
Director of Regulatory Affairs
Labopharm Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER