NCT00642837

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
982

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

April 28, 2014

Status Verified

April 1, 2014

Enrollment Period

8 months

First QC Date

March 21, 2008

Last Update Submit

April 24, 2014

Conditions

Rheumatic Diseases

Keywords

Health-Related Quality of LifeKEQ-5DSleep disturbanceSleep qualitySF-1Pain intensityPain reliefTramadolAcetaminophen

Outcome Measures

Primary Outcomes (1)

  • KEQ-5D: Korean Version of EQ-5D which assess the health related quality of life of patient

    baseline and week 12

Secondary Outcomes (2)

  • Pain relief

    baseline & week 12

  • Pain intensity

    baseline & week 12

Study Arms (9)

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

Interventions

Tramadol/acetaminophenDRUG

Osteoarthritis, flexible dose depending on patients' pain relief

002

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with rheumatism who have moderate-to-severe pain

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rheumatic DiseasesParasomniasSleep Initiation and Maintenance DisordersPain

Interventions

Ultracet

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSleep Wake DisordersNervous System DiseasesMental DisordersSleep Disorders, IntrinsicDyssomniasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janssen Korea, Ltd. Clinical Trial

    Janssen Korea, Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2008

First Posted

March 25, 2008

Study Start

September 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

April 28, 2014

Record last verified: 2014-04