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A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets
This study has been completed.
Study NCT00642837   Information provided by Janssen Korea, Ltd., Korea
First Received: March 21, 2008   Last Updated: August 27, 2009   History of Changes

March 21, 2008
August 27, 2009
September 2007
 
KEQ-5D: Korean Version of EQ-5D which assess the health related quality of life of patient [ Time Frame: baseline and week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00642837 on ClinicalTrials.gov Archive Site
  • Pain relief [ Time Frame: baseline & week 12 ] [ Designated as safety issue: No ]
  • Pain intensity [ Time Frame: baseline & week 12 ] [ Designated as safety issue: No ]
Same as current
 
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

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

 
Observational
Other, Prospective
Rheumatic Diseases
Drug: Tramadol/acetaminophen
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
982
May 2008
 

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00642837
Clinical Research Director, Janssen Korea, Ltd., Korea
CR014803
Janssen Korea, Ltd., Korea
 
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
Janssen Korea, Ltd., Korea
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP