NCT00642837

A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets

Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets ; Multicenter, Open-label, Prospective, Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 982 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Rheumatic Diseases

Interventions

Type	Name	Description
DRUG	Tramadol/acetaminophen	Osteoarthritis, flexible dose depending on patients' pain relief
DRUG	Tramadol/acetaminophen	Post surgical neurophatic pain, flexible dose depending on patients' pain relief
DRUG	Tramadol/acetaminophen	Post traumatic neuropathic pain, flexible dose depending on patient pain relief
DRUG	Tramadol/acetaminophen	Spinal Cord Injury, flexible dose depending on patients' pain relief
DRUG	Tramadol/acetaminophen	Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
DRUG	Tramadol/acetaminophen	Diabetic Neuropathy, flexible dose depending on patients' pain relief
DRUG	Tramadol/acetaminophen	Post stroke pain, flexible dose depending on patients' pain relief
DRUG	Tramadol/acetaminophen	Low back pain, flexible dose depending on patients' pain relief
DRUG	Tramadol/acetaminophen	Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
DRUG	Tramadol/acetaminophen	Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-03-25
• Last updated: 2014-04-28