At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 981 enrolled
Drug / intervention
tapentadol (CG5503) ER +2 moredrug
Likely dose
tapentadol (CG5503) ER 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Subjects With Moderate to Severe Chronic Low Back Pain
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Mar 20, 2007·Updated Apr 30, 2012
In Brief
A Phase 3 clinical trial evaluating tapentadol (CG5503) ER, oxycodone CR, and 1 other intervention for Low Back Pain. Completed, enrolled 981 participants.
Detailed Summary
The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administrated tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain of the lower back, in comparison with placebo and Oxycodone Controlled Release (CR).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
Countries--
CollaboratorsGrünenthal GmbH
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
First PostedMar 2007
Primary CompletionMay 2008
TodayJul 2026
First PostedMar 20, 2007
Enrollment StartFeb 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.3 years ago
Interventions
tapentadol (CG5503) ERdrug
50, 100, 150, 200, 250 mg twice daily for 15 weeks
oxycodone CRdrug
10, 20, 30, 40, 50 mg twice daily for 15 weeks
placebodrug
matching placebo twice daily for 15 weeks