Trial · NCT00950651
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
NCT00950651, Phase 3, Completed, Labopharm Inc.; results first posted 2009-08-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT00950651. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00950651
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT00950651
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 431 participants, actual
- Lead sponsor
- Labopharm Inc.
- Conditions
- Osteoarthritis, Knee, Pain
- Interventions
- Tramadol HCl Contramid® Once A Day, Tramadol HCl Twice a day
- First posted
- 2009-08-03
- Last updated
- 2012-04-30
- Results first posted
- 2009-08-03
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12 | Baseline to week 12 | 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. |
| Secondary | Arthritis Pain at the End of Dosing Interval (24-hour Efficacy) | 12 weeks | 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). |
| Secondary | Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12 | Baseline to week 12 | 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. |
| Secondary | Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12 | Baseline to week 12 | 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 |
| Secondary | Percentage of Change From Baseline in WOMAC Total Score at Week 12 | Baseline to week 12 | 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. |
| Secondary | Percentage of Change From Baseline in Current Pain at Week 12 | Baseline to week 12 | 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. |
| Secondary | Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12 | Baseline to week 12 | 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. |
| Secondary | Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12 | Baseline to week 12 | 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. |
| Secondary | Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12 | Baseline to week 12 | 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. |
| Secondary | Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12 | Baseline to week 12 | 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12 | Baseline to week 12 | 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. | percentage of change | MEAN |
| SECONDARY | Arthritis Pain at the End of Dosing Interval (24-hour Efficacy) | 12 weeks | 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. | participants | NUMBER |
| SECONDARY | Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12 | Baseline to week 12 | 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. | percentage of change | MEAN |
| SECONDARY | Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12 | Baseline to week 12 | 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. | percentage of change | MEAN |
| SECONDARY | Percentage of Change From Baseline in WOMAC Total Score at Week 12 | Baseline to week 12 | 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. | percentage of change | MEAN |
| SECONDARY | Percentage of Change From Baseline in Current Pain at Week 12 | Baseline to week 12 | 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. | percentage of change | MEAN |
| SECONDARY | Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12 | Baseline to week 12 | 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. | percentage of change | MEAN |
| SECONDARY | Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12 | Baseline to week 12 | 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. | percentage of change | MEAN |
| SECONDARY | Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12 | Baseline to week 12 | 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. | percentage of change | MEAN |
| SECONDARY | Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12 | Baseline to week 12 | 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. | percentage of change | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12 | Tramadol HCl Contramid® Once A Day | 58.3 | Standard Deviation 29.9 | percentage of change | |
| Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12 | Tramadol HCl Twice a Day (SR) | 58.7 | Standard Deviation 27.0 | percentage of change | |
| Arthritis Pain at the End of Dosing Interval (24-hour Efficacy) | Tramadol HCl Contramid® Once A Day | None | 20 | participants | |
| Arthritis Pain at the End of Dosing Interval (24-hour Efficacy) | Tramadol HCl Twice a Day (SR) | None | 19 | participants | |
| Arthritis Pain at the End of Dosing Interval (24-hour Efficacy) | Tramadol HCl Contramid® Once A Day | Barely noticeable | 42 | participants | |
| Arthritis Pain at the End of Dosing Interval (24-hour Efficacy) | Tramadol HCl Twice a Day (SR) | Barely noticeable | 33 | participants | |
| Arthritis Pain at the End of Dosing Interval (24-hour Efficacy) | Tramadol HCl Contramid® Once A Day | Mild | 35 | participants | |
| Arthritis Pain at the End of Dosing Interval (24-hour Efficacy) | Tramadol HCl Twice a Day (SR) | Mild | 40 | participants | |
| Arthritis Pain at the End of Dosing Interval (24-hour Efficacy) | Tramadol HCl Contramid® Once A Day | Moderate | 35 | participants | |
| Arthritis Pain at the End of Dosing Interval (24-hour Efficacy) | Tramadol HCl Twice a Day (SR) | Moderate | 32 | participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tramadol HCl Contramid® Once A Day | 215 | |
| Overall Study | STARTED | Tramadol HCl Twice a Day (SR) | 216 | |
| Overall Study | COMPLETED | Tramadol HCl Contramid® Once A Day | 184 | |
| Overall Study | COMPLETED | Tramadol HCl Twice a Day (SR) | 181 | |
| Overall Study | NOT COMPLETED | Tramadol HCl Contramid® Once A Day | 31 | |
| Overall Study | NOT COMPLETED | Tramadol HCl Twice a Day (SR) | 35 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Tramadol HCl Contramid® Once A Day | 73 | 215 | 136 |
| other | Constipation | Gastrointestinal disorders | Tramadol HCl Twice a Day (SR) | 65 | 215 | 143 |
| other | Dizziness | Nervous system disorders | Tramadol HCl Contramid® Once A Day | 51 | 215 | 85 |
| other | Dizziness | Nervous system disorders | Tramadol HCl Twice a Day (SR) | 65 | 215 | 97 |
| other | Dry mouth | Gastrointestinal disorders | Tramadol HCl Contramid® Once A Day | 20 | 215 | 28 |
| other | Dry mouth | Gastrointestinal disorders | Tramadol HCl Twice a Day (SR) | 10 | 215 | 15 |
| other | Headache | Nervous system disorders | Tramadol HCl Contramid® Once A Day | 27 | 215 | 37 |
| other | Headache | Nervous system disorders | Tramadol HCl Twice a Day (SR) | 38 | 215 | 54 |
| other | Nausea | Gastrointestinal disorders | Tramadol HCl Contramid® Once A Day | 70 | 215 | 121 |
| other | Nausea | Gastrointestinal disorders | Tramadol HCl Twice a Day (SR) | 73 | 215 | 134 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tramadol HCl Contramid® Once A Day | ||
| Total, all-cause mortality | Tramadol HCl Twice a Day (SR) | ||
| Total, other adverse events | Tramadol HCl Contramid® Once A Day | 159 | 215 |
| Total, other adverse events | Tramadol HCl Twice a Day (SR) | 159 | 215 |
| Total, serious adverse events | Tramadol HCl Contramid® Once A Day | 3 | 215 |
| Total, serious adverse events | Tramadol HCl Twice a Day (SR) | 8 | 215 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17523716 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tramadol HCl Contramid® Once A Day vs Tramadol HCl Twice a Day (SR): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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