Pain
Conditions
Keywords
Pain due to Osteoarthritis of the Knee
Brief summary
The objective of this study is to compare the analgesic efficacy and safety of Tramadol Once a Day 100, 200, 300 mg and Placebo
Interventions
One Tramadol Once A Day tablet at randomized dose daily.
DRUGPlacebo
One Placebo tablet daily.
Sponsors
Labopharm Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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: * Current knee pain. * Less than 30 minutes of morning stiffness with or without crepitus on active motion. * Confirmation either by arthroscopy or radiologist's report (X-rays showing osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation}) within five years prior to entry into the study. 2. CRP \< 8 ug/mL (if available at local lab) or ESR \< 40 mm/hr. 3. Total WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Pain Subscale Score of \> 150 mm at Baseline corresponding with moderate to severe Osteoarthritis. 4. Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials. 5. 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
1. Known rheumatoid arthritis or any other rheumatoid disease. 2. Secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; ochronosis; haemochromatosis; osteochondromatosis; or collagen gene mutations. 3. Evidence of effusion greater than 15 cc upon physical examination of the joint at Baseline (Visit 1). 4. BMI greater than or equal to 38. 5. Major illness, requiring hospitalization during the 3 months before commencement of the screening period. 6. Unwillingness to stop taking pain medication (for arthritis or other types of pain) or was unwilling to stop taking other medications for the treatment of OA. 7. Previous failure or discontinuation (due to adverse events) of tramadol HCl therapy. 8. Treatment within the last 3 weeks with any of the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; or any other drug that reduces seizure threshold. 9. Treatment with another investigational agent within the last 30 days. 10. A history of seizure disorder other than Infantile Febrile Seizures. 11. Previous or current opioid dependency. 12. Bowel disease causing malabsorption. 13. Pregnancy or lactating or childbearing potential and unwilling to utilize a medically approved method of contraception during participation in this clinical trial. 14. Significant liver disease, defined as active hepatitis or elevated liver enzymes \>3 times the upper boundary of the normal range. 15. Significant renal disease, defined as creatinine clearance \<30 mL/min as estimated by the method of Levey et al., 1999. 16. Current substance abuse or dependence, other than nicotine. 17. Allergy or adverse reaction to tramadol or any structurally similar drugs e.g. opiates. 18. Any other condition that, in the opinion of the Investigators, would have adversely affected the patient's ability to complete the study or its measures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Rating of Pain for the Study Period (12 Weeks) | 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. |
| Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12) | 12 weeks | 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. |
| Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12) | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Rating of Pain Relief | 12 weeks | 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. |
| Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 0, week 3, week 6 | 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. |
| Dropout Rate | 12 weeks | Reasons for withdrawal from the trial were collected |
| Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 0, week 3, week 6 | 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). |
| Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | 12 weeks | Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1: Tramadol Once A Day 100mg | 106 |
| 2: Tramadol Once A Day 200mg | 111 |
| 3: Tramadol Once A Day 300mg | 108 |
| 4: Placebo | 227 |
| Total | 552 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 13 | 20 | 35 | 17 |
| Overall Study | Death | 0 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 21 | 11 | 11 | 47 |
| Overall Study | Physician Decision | 6 | 7 | 2 | 19 |
| Overall Study | Withdrawal by Subject | 4 | 8 | 10 | 9 |
Baseline characteristics
| Characteristic | 1: Tramadol Once A Day 100mg | 2: Tramadol Once A Day 200mg | 3: Tramadol Once A Day 300mg | 4: Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 48 Participants | 50 Participants | 36 Participants | 91 Participants | 225.0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 61 Participants | 72 Participants | 136 Participants | 327.0 Participants |
| Age Continuous | 62.9 years STANDARD_DEVIATION 8.3 | 61.1 years STANDARD_DEVIATION 9.1 | 60.3 years STANDARD_DEVIATION 9.4 | 61.1 years STANDARD_DEVIATION 9.7 | 61.3 years STANDARD_DEVIATION 9.3 |
| Sex: Female, Male Female | 65 Participants | 67 Participants | 72 Participants | 140 Participants | 344.0 Participants |
| Sex: Female, Male Male | 41 Participants | 44 Participants | 36 Participants | 87 Participants | 208.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 30 / — | 55 / — | 56 / — | 37 / — |
| serious Total, serious adverse events | 1 / — | 0 / — | 1 / — | 2 / — |
Outcome results
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.
Time frame: 12 weeks
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1: Tramadol Once A Day 100mg | Patient Global Rating of Pain for the Study Period (12 Weeks) | Very effective | 19 participants |
| 1: Tramadol Once A Day 100mg | Patient Global Rating of Pain for the Study Period (12 Weeks) | Ineffective | 34 participants |
| 1: Tramadol Once A Day 100mg | Patient Global Rating of Pain for the Study Period (12 Weeks) | Effective | 49 participants |
| 2: Tramadol Once A Day 200mg | Patient Global Rating of Pain for the Study Period (12 Weeks) | Very effective | 25 participants |
| 2: Tramadol Once A Day 200mg | Patient Global Rating of Pain for the Study Period (12 Weeks) | Ineffective | 27 participants |
| 2: Tramadol Once A Day 200mg | Patient Global Rating of Pain for the Study Period (12 Weeks) | Effective | 55 participants |
| 3: Tramadol Once A Day 300mg | Patient Global Rating of Pain for the Study Period (12 Weeks) | Very effective | 27 participants |
| 3: Tramadol Once A Day 300mg | Patient Global Rating of Pain for the Study Period (12 Weeks) | Effective | 57 participants |
| 3: Tramadol Once A Day 300mg | Patient Global Rating of Pain for the Study Period (12 Weeks) | Ineffective | 21 participants |
| 4: Placebo | Patient Global Rating of Pain for the Study Period (12 Weeks) | Very effective | 28 participants |
| 4: Placebo | Patient Global Rating of Pain for the Study Period (12 Weeks) | Ineffective | 93 participants |
| 4: Placebo | Patient Global Rating of Pain for the Study Period (12 Weeks) | Effective | 102 participants |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1: Tramadol Once A Day 100mg | Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12) | 41.6 Percentage difference in WOMAC Pain | Standard Deviation 50.2 |
| 2: Tramadol Once A Day 200mg | Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12) | 42.8 Percentage difference in WOMAC Pain | Standard Deviation 46.4 |
| 3: Tramadol Once A Day 300mg | Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12) | 46.0 Percentage difference in WOMAC Pain | Standard Deviation 39.9 |
| 4: Placebo | Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12) | 32.3 Percentage difference in WOMAC Pain | Standard Deviation 48.2 |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1: Tramadol Once A Day 100mg | Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12) | 42.3 Percentage difference in WOMAC Physical | Standard Deviation 46.1 |
| 2: Tramadol Once A Day 200mg | Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12) | 42.0 Percentage difference in WOMAC Physical | Standard Deviation 39.5 |
| 3: Tramadol Once A Day 300mg | Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12) | 38.7 Percentage difference in WOMAC Physical | Standard Deviation 70 |
| 4: Placebo | Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12) | 30.9 Percentage difference in WOMAC Physical | Standard Deviation 44.4 |
Secondary
Dropout Rate
Reasons for withdrawal from the trial were collected
Time frame: 12 weeks
Population: Safety population: all randomized patients who received at least one dose of the assigned study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1: Tramadol Once A Day 100mg | Dropout Rate | Adverse events | 12.3 percentage of participants |
| 1: Tramadol Once A Day 100mg | Dropout Rate | Patient request | 3.8 percentage of participants |
| 1: Tramadol Once A Day 100mg | Dropout Rate | Death | 0 percentage of participants |
| 1: Tramadol Once A Day 100mg | Dropout Rate | Investigator initiated discontinuation | 5.7 percentage of participants |
| 1: Tramadol Once A Day 100mg | Dropout Rate | Lack of efficacy | 19.8 percentage of participants |
| 2: Tramadol Once A Day 200mg | Dropout Rate | Investigator initiated discontinuation | 6.3 percentage of participants |
| 2: Tramadol Once A Day 200mg | Dropout Rate | Adverse events | 18.0 percentage of participants |
| 2: Tramadol Once A Day 200mg | Dropout Rate | Death | 0 percentage of participants |
| 2: Tramadol Once A Day 200mg | Dropout Rate | Patient request | 7.2 percentage of participants |
| 2: Tramadol Once A Day 200mg | Dropout Rate | Lack of efficacy | 9.9 percentage of participants |
| 3: Tramadol Once A Day 300mg | Dropout Rate | Investigator initiated discontinuation | 1.9 percentage of participants |
| 3: Tramadol Once A Day 300mg | Dropout Rate | Lack of efficacy | 10.2 percentage of participants |
| 3: Tramadol Once A Day 300mg | Dropout Rate | Patient request | 9.3 percentage of participants |
| 3: Tramadol Once A Day 300mg | Dropout Rate | Adverse events | 32.4 percentage of participants |
| 3: Tramadol Once A Day 300mg | Dropout Rate | Death | 0 percentage of participants |
| 4: Placebo | Dropout Rate | Adverse events | 7.5 percentage of participants |
| 4: Placebo | Dropout Rate | Patient request | 4.0 percentage of participants |
| 4: Placebo | Dropout Rate | Lack of efficacy | 20.7 percentage of participants |
| 4: Placebo | Dropout Rate | Investigator initiated discontinuation | 8.4 percentage of participants |
| 4: Placebo | Dropout Rate | Death | 0.4 percentage of participants |
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.
Time frame: 12 weeks
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1: Tramadol Once A Day 100mg | Investigator Global Rating of Pain Relief | Very effective | 20 participants |
| 1: Tramadol Once A Day 100mg | Investigator Global Rating of Pain Relief | Ineffective | 35 participants |
| 1: Tramadol Once A Day 100mg | Investigator Global Rating of Pain Relief | Effective | 46 participants |
| 2: Tramadol Once A Day 200mg | Investigator Global Rating of Pain Relief | Very effective | 26 participants |
| 2: Tramadol Once A Day 200mg | Investigator Global Rating of Pain Relief | Ineffective | 28 participants |
| 2: Tramadol Once A Day 200mg | Investigator Global Rating of Pain Relief | Effective | 53 participants |
| 3: Tramadol Once A Day 300mg | Investigator Global Rating of Pain Relief | Effective | 61 participants |
| 3: Tramadol Once A Day 300mg | Investigator Global Rating of Pain Relief | Very effective | 26 participants |
| 3: Tramadol Once A Day 300mg | Investigator Global Rating of Pain Relief | Ineffective | 17 participants |
| 4: Placebo | Investigator Global Rating of Pain Relief | Very effective | 26 participants |
| 4: Placebo | Investigator Global Rating of Pain Relief | Ineffective | 95 participants |
| 4: Placebo | Investigator Global Rating of Pain Relief | Effective | 102 participants |
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).
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1: Tramadol Once A Day 100mg | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Lunchtime (last individual visit) | 35.1 mm | Standard Deviation 29.4 |
| 1: Tramadol Once A Day 100mg | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Before next morning dose (last individual visit) | 35.9 mm | Standard Deviation 31.3 |
| 1: Tramadol Once A Day 100mg | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Bed time (last individual visit) | 37.0 mm | Standard Deviation 31.4 |
| 2: Tramadol Once A Day 200mg | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Lunchtime (last individual visit) | 32.0 mm | Standard Deviation 25.2 |
| 2: Tramadol Once A Day 200mg | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Before next morning dose (last individual visit) | 34.3 mm | Standard Deviation 27.6 |
| 2: Tramadol Once A Day 200mg | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Bed time (last individual visit) | 34.3 mm | Standard Deviation 26 |
| 3: Tramadol Once A Day 300mg | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Bed time (last individual visit) | 34.7 mm | Standard Deviation 29.9 |
| 3: Tramadol Once A Day 300mg | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Lunchtime (last individual visit) | 34.4 mm | Standard Deviation 28.6 |
| 3: Tramadol Once A Day 300mg | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Before next morning dose (last individual visit) | 34.8 mm | Standard Deviation 29.1 |
| 4: Placebo | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Lunchtime (last individual visit) | 38.9 mm | Standard Deviation 30.5 |
| 4: Placebo | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Before next morning dose (last individual visit) | 40.6 mm | Standard Deviation 31.5 |
| 4: Placebo | Multiple Dose Effect Using 24-hour VAS Pain Questionnaire | Bed time (last individual visit) | 41.9 mm | Standard Deviation 32.6 |
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.
Time frame: Week 0, week 3, week 6
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1: Tramadol Once A Day 100mg | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 0 (Visit 2) | 30.0 Percentage difference in WOMAC Pain | Standard Deviation 41.1 |
| 1: Tramadol Once A Day 100mg | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 6 (Visit 4) | 58.2 Percentage difference in WOMAC Pain | Standard Deviation 39.3 |
| 1: Tramadol Once A Day 100mg | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 3 (Visit 3) | 56.4 Percentage difference in WOMAC Pain | Standard Deviation 39.2 |
| 2: Tramadol Once A Day 200mg | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 0 (Visit 2) | 34.5 Percentage difference in WOMAC Pain | Standard Deviation 41.5 |
| 2: Tramadol Once A Day 200mg | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 6 (Visit 4) | 48.8 Percentage difference in WOMAC Pain | Standard Deviation 39.8 |
| 2: Tramadol Once A Day 200mg | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 3 (Visit 3) | 46.4 Percentage difference in WOMAC Pain | Standard Deviation 37.7 |
| 3: Tramadol Once A Day 300mg | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 3 (Visit 3) | 51.7 Percentage difference in WOMAC Pain | Standard Deviation 41.9 |
| 3: Tramadol Once A Day 300mg | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 0 (Visit 2) | 33.0 Percentage difference in WOMAC Pain | Standard Deviation 44.6 |
| 3: Tramadol Once A Day 300mg | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 6 (Visit 4) | 57.2 Percentage difference in WOMAC Pain | Standard Deviation 37.6 |
| 4: Placebo | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 0 (Visit 2) | 19.4 Percentage difference in WOMAC Pain | Standard Deviation 36.5 |
| 4: Placebo | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 6 (Visit 4) | 44.7 Percentage difference in WOMAC Pain | Standard Deviation 41.8 |
| 4: Placebo | Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 3 (Visit 3) | 37.8 Percentage difference in WOMAC Pain | Standard Deviation 40 |
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).
Time frame: Week 0, week 3, week 6
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1: Tramadol Once A Day 100mg | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 0 (Visit 2) | 32.0 Percentage difference in WOMAC Physical | Standard Deviation 36.8 |
| 1: Tramadol Once A Day 100mg | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 6 (Visit 4) | 56.2 Percentage difference in WOMAC Physical | Standard Deviation 37.6 |
| 1: Tramadol Once A Day 100mg | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 3 (Visit 3) | 54.9 Percentage difference in WOMAC Physical | Standard Deviation 37.9 |
| 2: Tramadol Once A Day 200mg | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 0 (Visit 2) | 29.8 Percentage difference in WOMAC Physical | Standard Deviation 35.6 |
| 2: Tramadol Once A Day 200mg | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 6 (Visit 4) | 44.2 Percentage difference in WOMAC Physical | Standard Deviation 40 |
| 2: Tramadol Once A Day 200mg | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 3 (Visit 3) | 43.5 Percentage difference in WOMAC Physical | Standard Deviation 37.1 |
| 3: Tramadol Once A Day 300mg | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 3 (Visit 3) | 50.4 Percentage difference in WOMAC Physical | Standard Deviation 36.8 |
| 3: Tramadol Once A Day 300mg | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 0 (Visit 2) | 34.5 Percentage difference in WOMAC Physical | Standard Deviation 35.9 |
| 3: Tramadol Once A Day 300mg | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 6 (Visit 4) | 53.5 Percentage difference in WOMAC Physical | Standard Deviation 58.9 |
| 4: Placebo | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 0 (Visit 2) | 17.2 Percentage difference in WOMAC Physical | Standard Deviation 36 |
| 4: Placebo | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 6 (Visit 4) | 39.5 Percentage difference in WOMAC Physical | Standard Deviation 41.3 |
| 4: Placebo | Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4) | Week 3 (Visit 3) | 34.4 Percentage difference in WOMAC Physical | Standard Deviation 38.6 |