A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets
April 24, 2014 updated by: Janssen Korea, Ltd., Korea
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Observational
Enrollment (Actual)
982
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with rheumatism who have moderate-to-severe pain
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
001
|
Osteoarthritis, flexible dose depending on patients' pain relief
Post surgical neurophatic pain, flexible dose depending on patients' pain relief
Post traumatic neuropathic pain, flexible dose depending on patient pain relief
Spinal Cord Injury, flexible dose depending on patients' pain relief
Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
Diabetic Neuropathy, flexible dose depending on patients' pain relief
Post stroke pain, flexible dose depending on patients' pain relief
Low back pain, flexible dose depending on patients' pain relief
Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
|
|
002
|
Osteoarthritis, flexible dose depending on patients' pain relief
Post surgical neurophatic pain, flexible dose depending on patients' pain relief
Post traumatic neuropathic pain, flexible dose depending on patient pain relief
Spinal Cord Injury, flexible dose depending on patients' pain relief
Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
Diabetic Neuropathy, flexible dose depending on patients' pain relief
Post stroke pain, flexible dose depending on patients' pain relief
Low back pain, flexible dose depending on patients' pain relief
Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
|
|
003
|
Osteoarthritis, flexible dose depending on patients' pain relief
Post surgical neurophatic pain, flexible dose depending on patients' pain relief
Post traumatic neuropathic pain, flexible dose depending on patient pain relief
Spinal Cord Injury, flexible dose depending on patients' pain relief
Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
Diabetic Neuropathy, flexible dose depending on patients' pain relief
Post stroke pain, flexible dose depending on patients' pain relief
Low back pain, flexible dose depending on patients' pain relief
Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
|
|
004
|
Osteoarthritis, flexible dose depending on patients' pain relief
Post surgical neurophatic pain, flexible dose depending on patients' pain relief
Post traumatic neuropathic pain, flexible dose depending on patient pain relief
Spinal Cord Injury, flexible dose depending on patients' pain relief
Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
Diabetic Neuropathy, flexible dose depending on patients' pain relief
Post stroke pain, flexible dose depending on patients' pain relief
Low back pain, flexible dose depending on patients' pain relief
Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
|
|
005
|
Osteoarthritis, flexible dose depending on patients' pain relief
Post surgical neurophatic pain, flexible dose depending on patients' pain relief
Post traumatic neuropathic pain, flexible dose depending on patient pain relief
Spinal Cord Injury, flexible dose depending on patients' pain relief
Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
Diabetic Neuropathy, flexible dose depending on patients' pain relief
Post stroke pain, flexible dose depending on patients' pain relief
Low back pain, flexible dose depending on patients' pain relief
Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
|
|
006
|
Osteoarthritis, flexible dose depending on patients' pain relief
Post surgical neurophatic pain, flexible dose depending on patients' pain relief
Post traumatic neuropathic pain, flexible dose depending on patient pain relief
Spinal Cord Injury, flexible dose depending on patients' pain relief
Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
Diabetic Neuropathy, flexible dose depending on patients' pain relief
Post stroke pain, flexible dose depending on patients' pain relief
Low back pain, flexible dose depending on patients' pain relief
Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
|
|
007
|
Osteoarthritis, flexible dose depending on patients' pain relief
Post surgical neurophatic pain, flexible dose depending on patients' pain relief
Post traumatic neuropathic pain, flexible dose depending on patient pain relief
Spinal Cord Injury, flexible dose depending on patients' pain relief
Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
Diabetic Neuropathy, flexible dose depending on patients' pain relief
Post stroke pain, flexible dose depending on patients' pain relief
Low back pain, flexible dose depending on patients' pain relief
Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
|
|
008
|
Osteoarthritis, flexible dose depending on patients' pain relief
Post surgical neurophatic pain, flexible dose depending on patients' pain relief
Post traumatic neuropathic pain, flexible dose depending on patient pain relief
Spinal Cord Injury, flexible dose depending on patients' pain relief
Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
Diabetic Neuropathy, flexible dose depending on patients' pain relief
Post stroke pain, flexible dose depending on patients' pain relief
Low back pain, flexible dose depending on patients' pain relief
Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
|
|
009
|
Osteoarthritis, flexible dose depending on patients' pain relief
Post surgical neurophatic pain, flexible dose depending on patients' pain relief
Post traumatic neuropathic pain, flexible dose depending on patient pain relief
Spinal Cord Injury, flexible dose depending on patients' pain relief
Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
Diabetic Neuropathy, flexible dose depending on patients' pain relief
Post stroke pain, flexible dose depending on patients' pain relief
Low back pain, flexible dose depending on patients' pain relief
Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
KEQ-5D: Korean Version of EQ-5D which assess the health related quality of life of patient
Time Frame: baseline and week 12
|
baseline and week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain relief
Time Frame: baseline & week 12
|
baseline & week 12
|
|
Pain intensity
Time Frame: baseline & week 12
|
baseline & week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
March 21, 2008
First Submitted That Met QC Criteria
March 21, 2008
First Posted (Estimate)
March 25, 2008
Study Record Updates
Last Update Posted (Estimate)
April 28, 2014
Last Update Submitted That Met QC Criteria
April 24, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Rheumatic Diseases
- Collagen Diseases
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Acetaminophen
- Tramadol
Other Study ID Numbers
- CR014803
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.