Status:
COMPLETED
A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Chronic 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) with long term administration in participants with chronic pain.
Detailed Description
This is an open-label (both physician and participant know the name of the study drug), non-randomized, multicenter (when more than one hospital or medical school team work on a medical research study...
Eligibility Criteria
Inclusion
- Participants whose pain cannot be controlled sufficiently with at least 14-day continuous treatment with identical oral non steroid anti inflammatory drugs (NSAIDs) at a usual maximum dose during 3 months prior to this study
- Ambulatory participants without need for any supportive device or assistance during daily life
- Outpatients
- Participants who do not plan to change the therapeutic policy and content of the medications for underlying disease during screening period to the end of Treatment Period I
- Sustention of chronic pain due to Osteo Arthritis (OA), Low Back Pain (LBP), Rheumatoid Arthritis (RA), Neck Shoulder Arm Syndrome (NSAS), Diabetic Neuropathy (DN), Post herpetic Neuralgia (PHN) or other for at least 3 months
Exclusion
- Participants with conditions for which opioids are contraindicated
- Participants with conditions for which APAP are 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 :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00736957
Start Date
May 1 2008
End Date
November 1 2009
Last Update
July 2 2014
Active Locations (25)
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1
Chikushi, Japan
2
Chūō, Japan
3
Fukui, Japan
4
Fukuoka, Japan