drugset / Trial / NCT00736853

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

NCT00736853

Phase 3 Completed 321 enrolled Janssen Pharmaceutical K.K.
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2008-06
Primary completion
2009-01
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 325 mg Oral
Subject Acetaminophen Small molecule 650 mg Oral
Subject Tramadol Other / unclassified 37.5 mg Oral
Subject Tramadol Other / unclassified 75 mg Oral

Indications

No indication recorded.