Rheumatic DiseasesNCT00642837
A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets
An observational study of Rheumatic Diseases, run by Janssen Korea, Ltd., Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Tramadol/acetaminophen
- How many people
- 982 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with rheumatism who have moderate-to-severe pain
Who may be able to join
- 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.)
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
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
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.
Read 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 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
- Conditions
- Rheumatic Diseases
- Being tested
- Tramadol/acetaminophen
- Keywords
- Health-Related Quality of Life, KEQ-5D, Sleep disturbance, Sleep quality, SF-1, Pain intensity, Pain relief, Tramadol, Acetaminophen
- Medical subject headings
- Rheumatic Diseases, Parasomnias, Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol/acetaminophenDrug
Osteoarthritis, flexible dose depending on patients' pain relief
Tramadol/acetaminophenDrug
Post surgical neurophatic pain, flexible dose depending on patients' pain relief
Tramadol/acetaminophenDrug
Post traumatic neuropathic pain, flexible dose depending on patient pain relief
Tramadol/acetaminophenDrug
Spinal Cord Injury, flexible dose depending on patients' pain relief
Tramadol/acetaminophenDrug
Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief
Tramadol/acetaminophenDrug
Diabetic Neuropathy, flexible dose depending on patients' pain relief
Tramadol/acetaminophenDrug
Post stroke pain, flexible dose depending on patients' pain relief
Tramadol/acetaminophenDrug
Low back pain, flexible dose depending on patients' pain relief
Tramadol/acetaminophenDrug
Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
Tramadol/acetaminophenDrug
Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Drug: Tramadol/acetaminophen | |
| 002 | Not described Receives: Drug: Tramadol/acetaminophen | |
| 003 | Not described Receives: Drug: Tramadol/acetaminophen | |
| 004 | Not described Receives: Drug: Tramadol/acetaminophen | |
| 005 | Not described Receives: Drug: Tramadol/acetaminophen | |
| 006 | Not described Receives: Drug: Tramadol/acetaminophen | |
| 007 | Not described Receives: Drug: Tramadol/acetaminophen | |
| 008 | Not described Receives: Drug: Tramadol/acetaminophen | |
| 009 | Not described Receives: Drug: Tramadol/acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
KEQ-5D: Korean Version of EQ-5D which assess the health related quality of life of patient
Measured: baseline and week 12
Secondary outcomes (2)
Pain relief
Measured: baseline & week 12
Pain intensity
Measured: baseline & week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 982 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd. Clinical Trial, Study director, Janssen Korea, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642837
- Sponsor's protocol ID
- CR014803
- Status last verified
- Apr 2014
- First submitted
- 21 Mar 2008
- Last updated
- 28 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00642837
- Acronym / sponsor ID
- CR014803
- Conditions
- Rheumatic Diseases
- Keywords
- Health-Related Quality of Life, KEQ-5D, Sleep disturbance, Sleep quality, SF-1, Pain intensity, Pain relief, Tramadol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 982 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: Tramadol/acetaminophen |
| 002 | – | Drug: Tramadol/acetaminophen |
| 003 | – | Drug: Tramadol/acetaminophen |
| 004 | – | Drug: Tramadol/acetaminophen |
| 005 | – | Drug: Tramadol/acetaminophen |
| 006 | – | Drug: Tramadol/acetaminophen |
| 007 | – | Drug: Tramadol/acetaminophen |
| 008 | – | Drug: Tramadol/acetaminophen |
| 009 | – | Drug: Tramadol/acetaminophen |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rheumatism who have moderate-to-severe pain
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tramadol/acetaminophenOsteoarthritis, flexible dose depending on patients' pain relief | Drug | 002 |
| Tramadol/acetaminophenPost surgical neurophatic pain, flexible dose depending on patients' pain relief | Drug | 008 |
| Tramadol/acetaminophenPost traumatic neuropathic pain, flexible dose depending on patient pain relief | Drug | 009 |
| Tramadol/acetaminophenSpinal Cord Injury, flexible dose depending on patients' pain relief | Drug | 005 |
| Tramadol/acetaminophenFailed Back Surgery Syndrome,flexible dose depending on patients' pain relief | Drug | 006 |
| Tramadol/acetaminophenDiabetic Neuropathy, flexible dose depending on patients' pain relief | Drug | 003 |
| Tramadol/acetaminophenPost stroke pain, flexible dose depending on patients' pain relief | Drug | 007 |
| Tramadol/acetaminophenLow back pain, flexible dose depending on patients' pain relief | Drug | 001 |
| Tramadol/acetaminophenPost Herpetic Neuralgia, flexible dose depending on patients' pain relief | Drug | 004 |
| Tramadol/acetaminophenComplex Regional Pain Syndrome, flexible dose depending on patients' pain relief | Drug | 006 |
Primary outcome
KEQ-5D: Korean Version of EQ-5D which assess the health related quality of life of patient
Time frame: baseline and week 12
2 secondary outcomes
Pain relief
Time frame: baseline & week 12
Pain intensity
Time frame: baseline & week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
Related trials for Rheumatic Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd. Clinical Trial study director
Janssen Korea, Ltd.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases, run by Janssen Korea, Ltd., Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014.