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| ID | Type | Description | Link |
|---|---|---|---|
| NCT00852917 | Registry Identifier | ClinicalTrials.gov |
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The objective of this study is to compare the analgesic efficacy and safety of Tramadol Once a Day 100, 200, 300 mg and Placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Tramadol Once A Day 100mg | Experimental |
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| 2: Tramadol Once A Day 200mg | Experimental |
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| 3: Tramadol Once A Day 300mg | Experimental |
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| 4: Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol Once A Day | Drug | One Tramadol Once A Day tablet at randomized dose daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Rating of Pain for the Study Period (12 Weeks) | 3-item Likert-scale: "How do you rate overall pain relief with the drug?" with 3 possible answers: "very effective", "effective", or "ineffective". The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer. | 12 weeks |
| Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12) | Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 of the questions. | 12 weeks |
| Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12) | Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no difficulty (0mm) to extreme difficulty (100mm). The WOMAC Physical Function subscale results from the sum of 17 of the questions. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions. |
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Inclusion Criteria:
Males or Females between the ages of 40-75 with a diagnosis of moderate to severe osteoarthritis of the knee, consistent with the ACR Clinical Classification Criteria for Arthritis of the Knee:
CRP < 8 ug/mL (if available at local lab) or ESR < 40 mm/hr.
Total WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Pain Subscale Score of > 150 mm at Baseline corresponding with moderate to severe Osteoarthritis.
Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
REB approval of the written Informed Consent Form in Spanish or English which was signed and dated by the patient and Investigator, prior to study participation.
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18181382 | Result | Fishman RL, Kistler CJ, Ellerbusch MT, Aparicio RT, Swami SS, Shirley ME, Jain AK, Fortier L, Robertson S, Bouchard S. Efficacy and safety of 12 weeks of osteoarthritic pain therapy with once-daily tramadol (Tramadol Contramid OAD). J Opioid Manag. 2007 Sep-Oct;3(5):273-80. doi: 10.5055/jom.2007.0015. |
| Label | URL |
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| Approved labelling | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1: Tramadol Once A Day 100mg | |
| FG001 | 2: Tramadol Once A Day 200mg | |
| FG002 | 3: Tramadol Once A Day 300mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | One Placebo tablet daily. |
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| Week 0, week 3, week 6 |
| Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales. The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no difficulty (0mm) to extreme difficulty (100mm). | Week 0, week 3, week 6 |
| Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm). | 12 weeks |
| Investigator Global Rating of Pain Relief | The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: "How do you rate this patient's overall pain relief with the drug?" with 3 possible answers: "very effective", "effective", or "ineffective". | 12 weeks |
| Dropout Rate | Reasons for withdrawal from the trial were collected | 12 weeks |
| FG003 | 4: Placebo |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1: Tramadol Once A Day 100mg | |
| BG001 | 2: Tramadol Once A Day 200mg | |
| BG002 | 3: Tramadol Once A Day 300mg | |
| BG003 | 4: Placebo | |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Patient Global Rating of Pain for the Study Period (12 Weeks) | 3-item Likert-scale: "How do you rate overall pain relief with the drug?" with 3 possible answers: "very effective", "effective", or "ineffective". The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer. | The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale) | Posted | Number | participants | 12 weeks |
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| Primary | Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12) | Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 of the questions. | The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value. | Posted | Mean | Standard Deviation | Percentage difference in WOMAC Pain | 12 weeks |
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| Secondary | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions. | The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale) | Posted | Mean | Standard Deviation | Percentage difference in WOMAC Pain | Week 0, week 3, week 6 |
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| Secondary | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales. The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no difficulty (0mm) to extreme difficulty (100mm). | The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale) | Posted | Mean | Standard Deviation | Percentage difference in WOMAC Physical | Week 0, week 3, week 6 |
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| Secondary | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm). | The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value. | Posted | Mean | Standard Deviation | mm | 12 weeks |
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| Secondary | Investigator Global Rating of Pain Relief | The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: "How do you rate this patient's overall pain relief with the drug?" with 3 possible answers: "very effective", "effective", or "ineffective". | The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale) | Posted | Number | participants | 12 weeks |
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| Primary | Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12) | Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no difficulty (0mm) to extreme difficulty (100mm). The WOMAC Physical Function subscale results from the sum of 17 of the questions. | The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value. | Posted | Mean | Standard Deviation | Percentage difference in WOMAC Physical | 12 weeks |
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| Secondary | Dropout Rate | Reasons for withdrawal from the trial were collected | Safety population: all randomized patients who received at least one dose of the assigned study medication. | Posted | Number | percentage of participants | 12 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | 1: Tramadol Once A Day 100mg | 1 | 30 | |||||
| EG001 | 2: Tramadol Once A Day 200mg | 0 | 55 | |||||
| EG002 | 3: Tramadol Once A Day 300mg | 1 | 56 | |||||
| EG003 | 4: Placebo | 2 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Small intestinal obstruction Not Otherwise Specified (NOS) | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastritis Not Otherwise Specified (NOS) | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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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
| Title | Organization | Phone | Extension | |
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| Director of Regulatory Affairs | Labopharm Inc. | 1 450 686 1017 |
| ID | Term |
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| D010146 | Pain |
| ID | Term |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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