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.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00642837
First received: March 21, 2008
Last updated: April 24, 2014
Last verified: April 2014
  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 Phase
Rheumatic Diseases
Drug: Tramadol/acetaminophen
Phase 4

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:


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
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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 24, 2014
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
Tramadol
Acetaminophen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Antipyretics

ClinicalTrials.gov processed this record on October 19, 2014