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”

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

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.

Inclusion Criteria:

• Patients with rheumatism who have moderate-to-severe pain
• Patients who have not been administered Ultracet or tramadol over the last one month
• Patients who have signed a consent form indicating that they understand the purpose of and procedures required for the study (As for minors between 12 and 20 years old, the patients' legally acceptable representatives' signature is also required.)

Exclusion Criteria:

• Patients who have experienced failure of tramadol therapy or discontinued Tramadol because of adverse events
• Patients with impaired physical function or disease which may cause drug absorption anomaly, excess storage and metabolic or elimination disorder
• Patients who meet any of the prohibitions of tramadol or acetaminophen {Patients who are hypersensitive to active ingredients of the study drug:
• 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}
• Patients who are pregnant or of childbearing potential during the study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen Korea, Ltd., Korea

Overall Clinical Trial Officials and Contacts

Janssen Korea, Ltd. Clinical Trial Study Director Janssen Korea, Ltd., Korea  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642837

Study ID Number: CR014803

ClinicalTrials.gov Identifier: NCT00642837

Health Authority: Korea: Food and Drug Administration