Clinical trial NCT00642837: A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatic Diseases
Keywords: Health-Related Quality of Life
KEQ-5D
Sleep disturbance
Sleep quality
SF-1
Pain intensity
Pain relief
Tramadol
Acetaminophen
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 982
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rheumatism who have moderate-to-severe pain

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: KEQ-5D: Korean Version of EQ-5D which assess the health related quality of life of patient
timeFrame: baseline and week 12
Secondary outcomes:
measure: Pain relief
timeFrame: baseline & week 12
measure: Pain intensity
timeFrame: baseline & week 12
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd.
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: