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

Rheumatic Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642837
• Other study ID #: CR014803
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2008
• Last updated: April 24, 2014
• Start date: September 2007
• Est. completion date: May 2008

Study information

• Verified date: April 2014
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 982
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 (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

• Hypersensitive to active ingredients of the study drug

• Addicted to drugs acting on central nervous system including alcohol, hypnotics, centrally acting analgesics, opiates and psychotropics, serious respiratory depression (the study drug may cause mild respiratory depression)

• Patients with head injury and brain lesion who have the risk of decreased meantal awareness

• 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Rheumatic Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KEQ-5D: Korean Version of EQ-5D which assess the health related quality of life of patient		baseline and week 12	No
Secondary	Pain relief		baseline & week 12	No
Secondary	Pain intensity		baseline & week 12	No