A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain

PHASE3CompletedINTERVENTIONAL

Enrollment

981

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

Conditions

Low Back Pain

Interventions

DRUG

tapentadol (CG5503) ER

50, 100, 150, 200, 250 mg twice daily for 15 weeks

DRUG

oxycodone CR

10, 20, 30, 40, 50 mg twice daily for 15 weeks

DRUG

placebo

matching placebo twice daily for 15 weeks