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.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00642837
First received: March 21, 2008
Last updated: April 24, 2014
Last verified: April 2014

March 21, 2008
April 24, 2014
September 2007
May 2008   (final data collection date for primary outcome measure)
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 ]
Not Provided
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 ]
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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
Time Perspective: Prospective
Not Provided
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Probability Sample

Patients with rheumatism who have moderate-to-severe pain

Rheumatic Diseases
  • 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
  • 001
    Intervention: Drug: Tramadol/acetaminophen
  • 002
    Intervention: Drug: Tramadol/acetaminophen
  • 003
    Intervention: Drug: Tramadol/acetaminophen
  • 004
    Intervention: Drug: Tramadol/acetaminophen
  • 005
    Intervention: Drug: Tramadol/acetaminophen
  • 006
    Interventions:
    • Drug: Tramadol/acetaminophen
    • Drug: Tramadol/acetaminophen
  • 007
    Intervention: Drug: Tramadol/acetaminophen
  • 008
    Intervention: Drug: Tramadol/acetaminophen
  • 009
    Intervention: Drug: Tramadol/acetaminophen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
982
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Not Provided
 
NCT00642837
CR014803
Not Provided
Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
Not Provided
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
Janssen Korea, Ltd., Korea
April 2014

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