Status:
COMPLETED
An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Pain
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive an...
Detailed Description
This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (test or experiment in which neither the person giving the treatment nor the ...
Eligibility Criteria
Inclusion
- Participants with sustention of chronic pain associated with OA or LBP for at least 3 months
- Participants whose pain cannot be controlled sufficiently with at least 14-day continuous treatment with identical oral NSAIDs at a usual maximum dose during 3 months prior to this study
- Outpatients
- Ambulatory participants without need for any supportive device or assistance during daily life
Exclusion
- Participants with conditions for which opioids are contraindicated
- Participants with conditions for which acetaminophen is contraindicated
- Participants with history of convulsion or the possibility of convulsive seizure
- Participants with concurrent, previous, or possible alcohol dependence, drug dependence, or narcotic addiction
- Pregnant participants or those who may be pregnant, lactating mothers, and participants who wish pregnancy during the study period
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00736853
Start Date
June 1 2008
End Date
January 1 2009
Last Update
September 26 2013
Active Locations (20)
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1
Aichi, Japan
2
Amagasaki, Japan
3
Chiba, Japan
4
Edogawa City, Japan