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

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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

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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

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1. Primary:

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

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Measure Type	Primary
Measure Title	Number of Subjects With Treatment-emergent Adverse Events (TEAE)
Measure Description	The number of subjects who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.
Time Frame	52 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set (All randomized subjects who took at least one dose of study medication).

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.

Measured Values

	Tapentadol (CG5503)	Oxycodone
Number of Participants Analyzed [units: participants]	894	223
Number of Subjects With Treatment-emergent Adverse Events (TEAE) [units: Participants]	766	202

No statistical analysis provided for Number of Subjects With Treatment-emergent Adverse Events (TEAE)

2. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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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
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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

Responsible Party:	Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Senior Director, Clinical Leader )
Study ID Numbers:	CR011074
Study First Received:	August 4, 2006
Results First Received:	July 24, 2009
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00361504 History of Changes
Health Authority:	United States: Food and Drug Administration