Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain

Phase 3 Completed 117 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Grünenthal GmbH · collab

RandomizedCrossoverTriple-blindTreatment

Summary

The objective of this study is to test the idea that the immediate-release (IR) form of tapentadol (CG5503) can be directly converted into an approximately equivalent total daily dose (TDD) of the extended-release (ER) form, and vice-versa, with equivalent safety and efficacy.

Timeline

Start: 2007-12
Primary completion: 2008-04
Completion: 2008-05

Publications

Etropolski MS, Okamoto A, Shapiro DY, Rauschkolb C. Dose conversion between tapentadol immediate and extended release for low back pain. Pain Physician. 2010 Jan-Feb;13(1):61-70.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tapentadol	Small molecule	50 mg	Oral
Subject	Tapentadol	Small molecule	75 mg	Oral
Subject	Tapentadol	Small molecule	100 mg	Oral
Subject	Tapentadol	Small molecule	150 mg	Oral
Subject	Tapentadol	Small molecule	200 mg	Oral
Subject	Tapentadol	Small molecule	250 mg	Oral

Indications

No indication recorded.