A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain

This study has been completed.

Study NCT00449176 Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

First Received on March 16, 2007. Last Updated on May 17, 2011 History of Changes

Results First Received: April 17, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Low Back Pain
Interventions:	Drug: tapentadol (CG5503) ER Drug: oxycodone CR Drug: placebo

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 21 February 2007 and 12 March 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), a double-blind active treatment period with titration period (duration 3 weeks) and maintenance period (duration 12 weeks).

Reporting Groups

	Description
Tapentadol ER	Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
Oxycodone CR	oxycodone controlled release(CR) 20-50mg twice daily(BID)
Placebo	Matching Placebo twice daily(BID)

Participant Flow: Overall Study

	Tapentadol ER	Oxycodone CR	Placebo
STARTED	318 ^[1]	328 ^[2]	319 ^[3]
COMPLETED	166	133	152
NOT COMPLETED	152	195	167
Withdrawal by Subject	39	43	59
Lost to Follow-up	13	8	12
Adverse Event	51	107	15
Lack of Efficacy	13	7	50
Study drug non-compliant	14	11	11
all other	22	19	20

[1]	3 randomly assigned to this treatment group did not take drug (of 321 subjects initially randomized)
[2]	6 randomly assigned to this treatment group did not take drug (of 334 subjects initially randomized)
[3]	5 randomly assigned to this group did not receive drug, 2 enrolled twice(of 326 subjects randomized)

Baseline Characteristics

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Reporting Groups

	Description
Tapentadol ER	Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
Oxycodone CR	oxycodone controlled release(CR) 20-50mg twice daily(BID)
Placebo	Matching Placebo twice daily(BID)

Baseline Measures

	Tapentadol ER	Oxycodone CR	Placebo	Total
Number of Participants [units: participants]	318	328	319	965
Age [units: years] Mean ± Standard Deviation	49.4 ± 13.21	50.0 ± 14.21	50.4 ± 14.05	49.9 ± 13.83
Gender [units: participants]
Female	194	181	184	559
Male	124	147	135	406

Outcome Measures

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1. Primary:

Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. [ Time Frame: Baseline and 12 weeks ]

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2. Secondary:

Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12. [ Time Frame: Baseline and 12 week endpoint ]

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3. Secondary:

Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. [ Time Frame: Baseline and 12 week endpoint ]

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4. Secondary:

Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12 [ Time Frame: Baseline and 12 week endpoint ]

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5. Secondary:

Number of Participants With Treatment Discontinuation Due to Lack of Efficacy [ Time Frame: Baseline and 12 weeks ]

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6. Secondary:

Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12 [ Time Frame: Baseline and 12 week endpoint ]

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7. Secondary:

Responder Analysis 50% Improvement [ Time Frame: Baseline and Week 12 ]

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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:	Vice President, Compound Developmen Team Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00449176 History of Changes
Other Study ID Numbers:	CR013399
Study First Received:	March 16, 2007
Results First Received:	April 17, 2009
Last Updated:	May 17, 2011
Health Authority:	United States: Food and Drug Administration