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 on August 4, 2006. Last Updated on October 18, 2010 History of Changes

Results First Received: July 24, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Osteoarthritis, Hip Osteoarthritis, Knee Lower Back Pain Pain
Interventions:	Drug: oxycodone CR Drug: tapentadol (CG5503) PR

Participant Flow

Hide 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

Hide 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

Show All Outcome Measures

1. Primary:

Number of Subjects With Treatment-emergent Adverse Events (TEAE) [ Time Frame: 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) [ Time Frame: 52 Weeks ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Senior Director, Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
phone: 609-730-4537

No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications automatically indexed to this study:

Wild JE, Grond S, Kuperwasser B, Gilbert J, McCann B, Lange B, Steup A, Häufel T, Etropolski MS, Rauschkolb C, Lange R. Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain. Pain Pract. 2010 Sep-Oct;10(5):416-27.

Responsible Party:	Senior Director, Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00361504 History of Changes
Other Study ID Numbers:	CR011074
Study First Received:	August 4, 2006
Results First Received:	July 24, 2009
Last Updated:	October 18, 2010
Health Authority:	United States: Food and Drug Administration