CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,030 enrolled
Drug / intervention
oxycodone +2 moredrug
Likely dose
oxycodone 50mgfrom 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.

Search/NCT00421928
NCT00421928Phase 3Completed
CompareCT.gov

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 Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Jan 15, 2007·Updated Apr 18, 2012

In Brief

A Phase 3 clinical trial evaluating oxycodone, placebo, and 1 other intervention for Osteoarthritis, Knee and Pain. Completed, enrolled 1,030 participants.

Detailed Summary

The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee, Pain
Countries--
CollaboratorsGrünenthal GmbH

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 15, 2007
Enrollment StartJan 1, 2007
Primary CompletionJul 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.5 years ago

Interventions

oxycodonedrug

10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks

placebodrug

matching placebo twice a day (BID) during 15 weeks

tapentadol (CG5503)drug

50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks