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| ID | Type | Description | Link |
|---|---|---|---|
| NCT00832416 | Registry Identifier | ClinicalTrials.gov |
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The purpose 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 | Experimental |
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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 ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions. | Baseline to week 12 |
| 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 pain (0mm) to extreme pain (100mm). The WOMAC Physical Function subscale results from the sum of 17 questions. | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Difference 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 American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis of the Knee:
C-reactive protein (CRP) < 8 ug/ml (if available at local lab) or erythrocyte sedimentation rate (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.
Research Ethics Board (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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| Label | URL |
|---|---|
| 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 Difference 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 pain (0mm) to extreme pain (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 |
| Percentage of Participants Who Dropped Out From Trial by Dropout Reason | Reasons for withdrawal from the trial were collected and the percentage of participants who dropped out from trial were calculated by dropout reason | 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). Last Individual value. | 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 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). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value. | Posted | Mean | Standard Deviation | Percentage difference | Baseline to week 12 |
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| Secondary | Percentage Difference 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). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value. | Posted | Mean | Standard Deviation | Percentage difference | Week 0, week 3, week 6 |
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| Secondary | Percentage Difference 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 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 | Percentage difference | 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). Last Individual value. | 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 pain (0mm) to extreme pain (100mm). The WOMAC Physical Function subscale results from the sum of 17 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 | Baseline to week 12 |
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| Secondary | Percentage of Participants Who Dropped Out From Trial by Dropout Reason | Reasons for withdrawal from the trial were collected and the percentage of participants who dropped out from trial were calculated by dropout reason | 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 | 2 | 110 | 31 | 110 | |||
| EG001 | 2: Tramadol Once A Day 200mg | 1 | 113 | 49 | 113 | |||
| EG002 | 3: Tramadol Once A Day 300mg | 4 | 115 | 57 | 115 | |||
| EG003 | 4: Placebo | 3 | 227 | 38 | 227 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bipolar disorder NEC | Psychiatric disorders | Non-systematic Assessment |
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| Deep venous thrombosis NOS | Vascular disorders | Non-systematic Assessment |
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| Breast cancer invasive NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Aortic aneurysm | Vascular disorders | Non-systematic Assessment |
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| Pancreatitis aggravated | Gastrointestinal disorders | Non-systematic Assessment |
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| Thyroid neoplasm NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
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| Faecal impaction | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastroenteritis viral NOS | Gastrointestinal disorders | Non-systematic Assessment |
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| Rectal prolapse | Gastrointestinal disorders | Non-systematic Assessment |
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| Venous thrombosis NOS limb | Vascular 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 | Nervous system disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal 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 | |
|---|---|---|---|---|
| Director of Regulatory Affairs | Labopharm Inc. | 1 450 686 1017 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Ineffective |
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