Status:
COMPLETED
A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Rheumatic Diseases
Eligibility:
All Genders
12+ years
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...
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 dis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
982 Patients enrolled
Trial Details
Trial ID
NCT00642837
Start Date
September 1 2007
End Date
May 1 2008
Last Update
April 28 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.