A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets - Full Text View

Sponsor:	Janssen Korea, Ltd., Korea
Information provided by:	Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:	NCT00642837

Purpose

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.

Condition	Intervention
Rheumatic Diseases	Drug: Tramadol/acetaminophen

Study Type:	Observational
Study Design:	Time Perspective: Prospective
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

Resource links provided by NLM:

Drug Information available for: Tramadol Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Pain relief [ Time Frame: baseline & week 12 ] [ Designated as safety issue: No ]
Pain intensity [ Time Frame: baseline & week 12 ] [ Designated as safety issue: No ]

Enrollment:	982
Study Start Date:	September 2007
Study Completion Date:	May 2008

Groups/Cohorts	Assigned Interventions
001	Drug: Tramadol/acetaminophen Low back pain, flexible dose depending on patients' pain relief
002	Drug: Tramadol/acetaminophen Osteoarthritis, flexible dose depending on patients' pain relief
003	Drug: Tramadol/acetaminophen Diabetic Neuropathy, flexible dose depending on patients' pain relief
004	Drug: Tramadol/acetaminophen Post Herpetic Neuralgia, flexible dose depending on patients' pain relief
005	Drug: Tramadol/acetaminophen Spinal Cord Injury, flexible dose depending on patients' pain relief
006	Drug: Tramadol/acetaminophen Failed Back Surgery Syndrome,flexible dose depending on patients' pain relief Drug: Tramadol/acetaminophen Complex Regional Pain Syndrome, flexible dose depending on patients' pain relief
007	Drug: Tramadol/acetaminophen Post stroke pain, flexible dose depending on patients' pain relief
008	Drug: Tramadol/acetaminophen Post surgical neurophatic pain, flexible dose depending on patients' pain relief
009	Drug: Tramadol/acetaminophen Post traumatic neuropathic pain, flexible dose depending on patient pain relief

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

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with rheumatism who have moderate-to-severe pain

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642837

Sponsors and Collaborators

Janssen Korea, Ltd., Korea

Investigators

Study Director:

Janssen Korea, Ltd. Clinical Trial

Janssen Korea, Ltd.

More Information

No publications provided

Responsible Party:	Clinical Research Director, Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:	NCT00642837 History of Changes
Other Study ID Numbers:	CR014803
Study First Received:	March 21, 2008
Last Updated:	April 26, 2010
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:

Health-Related Quality of Life
KEQ-5D
Sleep disturbance
Sleep quality
SF-1

Pain intensity
Pain relief
Tramadol
Acetaminophen

Additional relevant MeSH terms:

Rheumatic Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Acetaminophen
Tramadol
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012