Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability

Summary

The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking WHO Step III analgesics and show lack of tolerability. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome. The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with that of tapentadol hydrochloride prolonged release treatment during defined periods of evaluation.

Timeline

Start

2009-10-30

Primary completion

2010-12

Completion

2011-01

Outcome

Met primary endpoint

Stopped (Enrollment): “This clinical trial was terminated early, due to slow recruitment and study drug shortages.”

paper Responder rate 1 at week 6 (last observation carried forward [LOCF]) was 80.9% (76/94; P < 0.0001 vs. the null responder hypothesis rate [<60%]) PMID 23475406 ↗

Publications

• Results Galvez R, Schafer M, Hans G, Falke D, Steigerwald I. Tapentadol prolonged release versus strong opioids for severe, chronic low back pain: results of an open-label, phase 3b study. Adv Ther. 2013 Mar;30(3):229-59. doi: 10.1007/s12325-013-0015-6. Epub 2013 Mar 7.

Drugs

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

Indications