An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain

Summary

The purpose of this study is to evaluate the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen compared with placebo in participants with chronic (lasting a long time) low-back pain.

Timeline

Start

2009-05

Primary completion

2009-10

Completion

2009-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Tramadol HCl/Acetaminophen vs Placebo; p = 0.0367; Cochran-Mantel-Haenszel NCT01112267 ↗

registry analysis (superiority or other test); Tramadol HCl/Acetaminophen vs Placebo; p = 0.0095; Mann-Whitney U test NCT01112267 ↗

Publications

• Lee JH, Lee CS; Ultracet ER Study Group. A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablet for the treatment of chronic low back pain. Clin Ther. 2013 Nov;35(11):1830-40. doi: 10.1016/j.clinthera.2013.09.017. Epub 2013 Oct 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	650 mg	Oral
Subject	Acetaminophen	Small molecule	1300 mg	Oral
Subject	Tramadol	Other / unclassified	75 mg	Oral
Subject	Tramadol	Other / unclassified	150 mg	Oral

Indications

No indication recorded.