An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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 and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Acetaminophen; Tramadol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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