Status:
COMPLETED
A Study to Assess the Improvement of Pain and Health-Related Quality of Life in Patients With Chronic Non-Malignant Pain Taking Tramadol Hydrochloride and Acetaminophen
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Chronic Pain
Eligibility:
All Genders
20+ years
Brief Summary
The purpose of this study is to evaluate the impact of extended release tramadol hydrochloride (75 mg) and acetaminophen (650 mg) tablets on improvement of pain.
Detailed Description
This is a multi-center (study conducted at multiple sites), open label (all people know the identity of the intervention), prospective (in which the participants are first identified and then followed...
Eligibility Criteria
Inclusion
- Patients with the prescription of ULTRACET ER for the treatment of moderate to severe pain
- Complaining of chronic pain for more than 3 months
Exclusion
- Patient who had been treated with extended release tramadol hydrochloride (75mg) and acetaminophen (650mg) or strong opioids (eg, morphine, fentanyl, oxycodone, hydromorphone) within the past 4 weeks
- Patient with a severe mental disease and with a medical history of hypersensitivity to opioid analgesics
- Pregnant females or the females likely to become pregnant during the study period
- Patient who had been believed likely to complain of more pain than the real pain he or she is experiencing because of industrial disaster, car insurance, and others
- Patients who are contraindicated according to the warnings, precautions and prohibitions regarding extended release tramadol hydrochloride (75mg) and acetaminophen (650mg)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
1065 Patients enrolled
Trial Details
Trial ID
NCT01819805
Start Date
September 1 2011
End Date
July 1 2012
Last Update
January 1 2015
Active Locations (14)
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1
Busan, South Korea
2
Cheonan, South Korea
3
Chungcheongbuk-Do, South Korea
4
Chungju, South Korea