Who is sponsoring NCT01112267?

NCT01112267 is sponsored by Janssen Korea, Ltd., Korea.

What condition does NCT01112267 study?

NCT01112267 studies Low Back Pain.

What drugs are being tested in NCT01112267?

Interventions: Tramadol HCl/acetaminophen Extended Release, Placebo, Tramadol HCl/acetaminophen Extended Release, Placebo.

What is the status of NCT01112267?

NCT01112267 is currently COMPLETED.

Last reviewed 2013-06-20 · How we verify

A Randomized, Placebo-Controlled, Parallel Group, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen Extended Release Tablet in Subjects With Chronic Low Back Pain

NCT01112267 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Janssen Korea, Ltd., Korea
Phase	Phase 3
Status	COMPLETED
Enrolment	248
Start date	2009-05
Completion	2009-10

Conditions

Low Back Pain

Interventions

Tramadol HCl/acetaminophen Extended Release
Placebo
Tramadol HCl/acetaminophen Extended Release
Placebo

Primary outcomes

Percentage of Participants With Reduction in Pain Intensity — Baseline up to Day 29
The percentage of participants with extent of reduction in pain intensity greater than or equal to 30 percent was reported. Pain intensity change rate was calculated by Visual Analog Scale (VAS) score at baseline minus VAS score at Day 29 divided by VAS score at Baseline. VAS is a 10 centimeter (cm) scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.
Change From Baseline in Pain Intensity at Day 29 — Baseline and Day 29
Change in pain intensity experienced by participants over the last 48 hours was measured on Day 29 against Baseline with VAS. VAS is a 10 cm scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.