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A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets
This study has been completed.
First Received: March 21, 2008   Last Updated: June 26, 2008   History of Changes
Sponsored by: Janssen Korea, Ltd., Korea
Information provided by: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00642837
  Purpose

The objective of the 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 Phase
Rheumatic Diseases
Phase IV

Drug Information available for: Tramadol Tramadol hydrochloride Acetaminophen CT 2584
U.S. FDA Resources
Study Type: Observational
Study Design: 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

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

Estimated Enrollment: 1100
Study Start Date: September 2007
Study Completion Date: April 2008
Detailed Description:

Recently the concerns about the Health-Related Quality of Life (HRQOL) have been increasing especially in chronic diseases. The 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 few studies have examined that Ultracet add-on treatment to nonsteroidal antiinflammatory drugs(NSAIDs) for osteoarthritis(OA) pain, fibromyalgia pain and chronic low back pain improved significantly HRQOL, compared with placebo. We will use EQ-5D in Korean version(KEQ-5D) to assess HRQOL. Because it is proved that the KEQ-5D have good validity and sensitivity 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.

This is an observational study which is performed under routine practice and Tramadol 37.5mg/Acetaminophen 325mg tablets dosage can be adjusted according to the response of each patient. Starting with 2 tablets and then 1 to 2 tablets as needed Q6H are recommended. It is not allowed to exceed 8 tablets per day. The treatment period is around 10~14 weeks.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (As 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 {Patients who are hypersensitive to active ingredients of the study drug:

Patients who are addicted to drugs acting on central nervous system including alcohol, hypnotics, centrally acting analgesics, opiates and psychotropics, Patients with serious respiratory depression (The study drug may cause mild respiratory depression.), Patients with head injury and brain lesion who have the risk of mental fog, 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., Korea
  More Information

No publications provided

Study ID Numbers: CR014803
Study First Received: March 21, 2008
Last Updated: June 26, 2008
ClinicalTrials.gov Identifier: NCT00642837     History of Changes
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
tramadol
Health-Related Quality of Life
Sleep disturbance
KEQ-5D
acetaminophen
SF-1
Pain intensity
Sleep quality
Pain relief

Study placed in the following topic categories:
Tramadol
Central Nervous System Depressants
Sleep Disorders
Dyssomnias
Quality of Life
Narcotics
Pain
Rheumatic Diseases
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Connective Tissue Diseases
Analgesics
Peripheral Nervous System Agents
Acetaminophen
Analgesics, Opioid

Additional relevant MeSH terms:
Tramadol
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Rheumatic Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Connective Tissue Diseases
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid
Acetaminophen

ClinicalTrials.gov processed this record on May 07, 2009