A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain

Summary

The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean patients with chronic, malignant, tumor-related cancer pain.

Timeline

Start

2010-08

Primary completion

2012-08

Completion

2012-08

Outcome

Met primary endpoint

paper The upper limit of the 95% CI was <1 (the predefined threshold value for non-inferiority), indicating that tapentadol ER provided analgesic efficacy that was non-inferior to that of oxycodone CR. PMID 23937387 ↗

paper Tapentadol ER (25-200 mg bid) provides analgesic efficacy that is non-inferior to that provided by oxycodone HCl CR PMID 23937387 ↗

Publications

• Imanaka K, Tominaga Y, Etropolski M, van Hove I, Ohsaka M, Wanibe M, Hirose K, Matsumura T. Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain. Curr Med Res Opin. 2013 Oct;29(10):1399-409. doi: 10.1185/03007995.2013.831816. Epub 2013 Aug 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Oxycodone	Other / unclassified	5 mg	Oral
Comparator	Oxycodone	Other / unclassified	40 mg	Oral
Subject	Tapentadol	Small molecule	25 mg	Oral
Subject	Tapentadol	Small molecule	200 mg	Oral

Indications

No indication recorded.