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

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

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Tapentadol Hydrochloride vs Placebo; Least Square (LS) Mean Difference -0.1 (95% CI -1.04 to 0.80) NCT01124604 ↗

Drugs

Indications