CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,123 enrolled
Drug / intervention
Oxycodone CR +1 moredrug
Likely dose
Oxycodone CR 10 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.

Search/NCT00361504
NCT00361504Phase 3Completed
CompareCT.gov

A One-Year, Randomized, Open-Label, Parallel-Arm, Phase 3 Long-Term Safety Trial, With Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR and Oxycodone CR in Subjects With Chronic Pain

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Aug 8, 2006·Updated Apr 29, 2014

In Brief

A Phase 3 clinical trial evaluating Oxycodone CR and Tapentadol (CG5503) ER for Osteoarthritis, Hip and 3 related conditions. Completed, enrolled 1,123 participants across 52 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the safety profile of tapentadol (CG5503) PR at doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients with at least a 3-month history of low back pain, or pain caused by knee or hip osteoarthritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Hip, Osteoarthritis, Knee, Lower Back Pain, Pain
CountriesCanada, United States
CollaboratorsGrünenthal GmbH

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2006
Enrollment StartNov 1, 2006
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.9 years ago

Interventions

Oxycodone CRdrug

Oxycodone CR 10 mg oral tablet BID administered for first 3 days, 20 mg oral tablet BID administered for next 4 days, 20 to 50 mg oral tablet BID administered for the next 51 weeks.

Tapentadol (CG5503) ERdrug

Tapentadol (CG5503) ER 50 mg oral tablet BID administered for first 3 days, 100 mg oral tablet BID administered for next 4 days, 100 to 250 mg oral tablet BID administered for the next 51 weeks.