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The objective of this observational study is to assess improvement of quality of life in the patients who are administered Tramadol 37.5mg/Acetaminophen 325mg tablets for 10~14 weeks according to the investigator's discretion in clinical practice.
Recently the concerns about the Health-Related Quality of Life (HRQOL) have been increasing especially in chronic diseases. Rheumatic disease is a chronic disease, which can result in a functional disability and impaired HRQOL. Because of this chronic pain, patients with rheumatic disease have lower scores on HRQOL than general population. A several studies have indicated Ultracet as an add-on treatment to nonsteroidal antiinflammatory drugs(NSAIDs) for osteoarthritis(OA) pain, fibromyalgia pain and chronic low back pain significantly improved HRQOL, compared with placebo. We will use the KEQ-5D (a Korean version of the EQ-5D which is a health related quality of life questionnaire) to assess HRQOL. The KEQ-5D has been shown to be effectively sensitive in several rheumatic conditions. The study hypothesis is that the quality of life will be improved after Tramadol 37.5mg/Acetaminophen 325mg tablets administration in outpatients who need Tramadol 37.5mg/Acetaminophen 325mg tablets administration at the investigator's discretion. This is a multicenter, open-label, prospective, observational study to compare HRQOL using Korean version of EQ-5D before and after the treatment with Tramadol 37.5mg/Acetaminophen 325mg tablets and to assess the correlation among each measurement. Observational Study - No investigational drug administered
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 |
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| 002 |
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| 003 |
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| 004 |
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| 005 |
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| 006 |
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| 007 |
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| 008 |
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| 009 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol/acetaminophen | Drug | Osteoarthritis, flexible dose depending on patients' pain relief |
| |
| Measure | Description | Time Frame |
|---|---|---|
| KEQ-5D: Korean Version of EQ-5D which assess the health related quality of life of patient | baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief | baseline & week 12 | |
| Pain intensity | baseline & week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with rheumatism who have moderate-to-severe pain
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd. | Study Director |
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|
| Tramadol/acetaminophen |
| Drug |
Post surgical neurophatic pain, flexible dose depending on patients' pain relief |
|
| Tramadol/acetaminophen | Drug | Post traumatic neuropathic pain, flexible dose depending on patient pain relief |
|
| Tramadol/acetaminophen | Drug | Spinal Cord Injury, flexible dose depending on patients' pain relief |
|
| Tramadol/acetaminophen | Drug | Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief |
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| Tramadol/acetaminophen | Drug | Diabetic Neuropathy, flexible dose depending on patients' pain relief |
|
| Tramadol/acetaminophen | Drug | Post stroke pain, flexible dose depending on patients' pain relief |
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| Tramadol/acetaminophen | Drug | Low back pain, flexible dose depending on patients' pain relief |
|
| Tramadol/acetaminophen | Drug | Post Herpetic Neuralgia, flexible dose depending on patients' pain relief |
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| Tramadol/acetaminophen | Drug | Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief |
|
| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| D020447 | Parasomnias |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C478659 | Ultracet |
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