A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy

Summary

The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR 50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours (SPID48) to measure analgesic effect in Korean patients with acute pain following bunionectomy.

Timeline

Start

2012-01

Primary completion

2013-02

Completion

2013-02

Outcome

Met primary endpoint

paper A treatment effect, favoring tapentadol IR, was observed for SPID48 (p < 0.001 for both doses vs. placebo, ANCOVA). PMID 25133962 ↗

paper The between-group difference (vs. placebo) in LS means of SPID48 was 76.4 (95% CI: 51.0, 101.7) for tapentadol IR 50 mg and 90.6 (95% CI: 65.1, 116.1) for tapentadol IR 75 mg. PMID 25133962 ↗

Publications

• Lee YK, Ko JS, Rhim HY, Lee EJ, Karcher K, Li H, Shapiro D, Lee HS. Acute postoperative pain relief with immediate-release tapentadol: randomized, double-blind, placebo-controlled study conducted in South Korea. Curr Med Res Opin. 2014 Dec;30(12):2561-70. doi: 10.1185/03007995.2014.954665. Epub 2014 Aug 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tapentadol	Small molecule	50 mg	Oral
Subject	Tapentadol	Small molecule	75 mg	Oral

Indications