A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain

This study has been completed.

Study NCT00361504 Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

First Received: August 4, 2006 Last Updated: September 14, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment
Conditions:	Osteoarthritis, Hip Osteoarthritis, Knee Lower Back Pain Pain
Interventions:	Drug: tapentadol (CG5503) PR Drug: oxycodone CR

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period for this out-patient, multicenter study occurred between 14 November 2006 and 25 July 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a screening period (duration up to 14 days), a washout period (duration 3 to 7 days), and an open label active treatment phase with titration and maintenance (total duration of 52 weeks).

Reporting Groups

	Description
Tapentadol (CG5503)	Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
Oxycodone	oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.

Participant Flow: Overall Study

	Tapentadol (CG5503)	Oxycodone
STARTED	894	223
COMPLETED	413	78
NOT COMPLETED	481	145
Withdrawal by Subject	94	31
Lost to Follow-up	40	7
Adverse Event	203	82
Lack of Efficacy	72	7
Resolution of Pain	2	0
Study medication non compliant	42	15
All other	28	3

Baseline Characteristics

Reporting Groups

	Description
Tapentadol (CG5503)	Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
Oxycodone	oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.

Baseline Measures

	Tapentadol (CG5503)	Oxycodone	Total
Number of Participants [units: participants]	894	223	1117
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	649	156	805
>=65 years	245	67	312
Age [units: years] Mean ± Standard Deviation	56.8 ± 12.51	58.1 ± 11.83	57.0 ± 12.38
Gender [units: participants]
Female	515	125	640
Male	379	98	477
Region of Enrollment [units: participants]
North America	684	170	854
Europe	210	53	263

Outcome Measures

1. Primary:

Number of Subjects With Treatment-emergent Adverse Events (TEAE) [ 52 weeks ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS) [ 52 Weeks ]

Show Outcome Measure 2