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Sponsored by: |
Janssen Korea, Ltd., Korea |
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Information provided by: | Janssen Korea, Ltd., Korea |
ClinicalTrials.gov Identifier: | NCT00642837 |
The objective of the 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.
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets ; Multicenter, Open-Label, Prospective, Observational Study |
Estimated Enrollment: | 1100 |
Study Start Date: | September 2007 |
Study Completion Date: | April 2008 |
Recently the concerns about the Health-Related Quality of Life (HRQOL) have been increasing especially in chronic diseases. The 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 few studies have examined that Ultracet add-on treatment to nonsteroidal antiinflammatory drugs(NSAIDs) for osteoarthritis(OA) pain, fibromyalgia pain and chronic low back pain improved significantly HRQOL, compared with placebo. We will use EQ-5D in Korean version(KEQ-5D) to assess HRQOL. Because it is proved that the KEQ-5D have good validity and sensitivity 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.
This is an observational study which is performed under routine practice and Tramadol 37.5mg/Acetaminophen 325mg tablets dosage can be adjusted according to the response of each patient. Starting with 2 tablets and then 1 to 2 tablets as needed Q6H are recommended. It is not allowed to exceed 8 tablets per day. The treatment period is around 10~14 weeks.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who are addicted to drugs acting on central nervous system including alcohol, hypnotics, centrally acting analgesics, opiates and psychotropics, Patients with serious respiratory depression (The study drug may cause mild respiratory depression.), Patients with head injury and brain lesion who have the risk of mental fog, Patients who are taking an MAO inhibitor or discontinued it no more than 2 weeks ago, Patients with peptic ulcer and severe hematological anomaly, Patients with severe hepatic impairment, renal impairment or cardiac dysfunction, Patients with aspirin-induced asthma (asthmatic attacks induced by nonsteroidal anti-inflammatory drug), Patients with epilepsy which is not controlled by a drug}
Study ID Numbers: | CR014803 |
Study First Received: | March 21, 2008 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00642837 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
tramadol Health-Related Quality of Life Sleep disturbance KEQ-5D acetaminophen |
SF-1 Pain intensity Sleep quality Pain relief |
Tramadol Central Nervous System Depressants Sleep Disorders Dyssomnias Quality of Life Narcotics Pain Rheumatic Diseases |
Musculoskeletal Diseases Analgesics, Non-Narcotic Connective Tissue Diseases Analgesics Peripheral Nervous System Agents Acetaminophen Analgesics, Opioid |
Tramadol Physiological Effects of Drugs Central Nervous System Depressants Narcotics Rheumatic Diseases Pharmacologic Actions Musculoskeletal Diseases Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Connective Tissue Diseases Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid Acetaminophen |