drugset / Trial / NCT01124604

An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants

NCT01124604

Phase 2 Completed 91 enrolled Janssen Pharmaceutical K.K.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.

Timeline

Start
2010-04
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tapentadol Small molecule 25 mg Oral
Subject Tapentadol Small molecule 250 mg Oral

Indications