A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Conditions:	Arthralgia. Pain Assessment Arthroplasty Replacement, Hip
Interventions:	Drug: Tapentadol IR (CG5503) Drug: Oxycodone HCL IR Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Tapentadol IR Fixed Dose 50 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol IR Fixed Dose 75 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol IR Fixed Dose 100 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Oxycodone HCL IR Fixed Dose 10 mg	oxycodone 10mg taken by mouth every 4-6 hours for 3 days
Placebo Fixed Dose	Matching placebo taken by mouth every 4-6 hours for 3 days

Participant Flow: Overall Study

	Tapentadol IR Fixed Dose 50 mg	Tapentadol IR Fixed Dose 75 mg	Tapentadol IR Fixed Dose 100 mg	Oxycodone HCL IR Fixed Dose 10 mg	Placebo Fixed Dose
STARTED	77	71	75	67	75
COMPLETED	35	31	30	36	24
NOT COMPLETED	42	40	45	31	51
Adverse Event	8	7	15	5	2
Withdrawal by Subject	4	8	6	6	6
Lack of Efficacy	22	22	21	17	42
Subject discharged from hospital	4	1	2	3	1
Variations in drug compliance	2	1	1	0	0
Non-compliance	1	0	0	0	0
Protocol Violation	1	1	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Tapentadol IR Fixed Dose 50 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol IR Fixed Dose 75 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol IR Fixed Dose 100 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Oxycodone HCL IR Fixed Dose 10 mg	oxycodone 10mg taken by mouth every 4-6 hours for 3 days
Placebo Fixed Dose	Matching placebo taken by mouth every 4-6 hours for 3 days

Baseline Measures

	Tapentadol IR Fixed Dose 50 mg	Tapentadol IR Fixed Dose 75 mg	Tapentadol IR Fixed Dose 100 mg	Oxycodone HCL IR Fixed Dose 10 mg	Placebo Fixed Dose	Total
Number of Participants [units: participants]	77	71	75	67	75	365
Age [units: years] Mean ± Standard Deviation	62.2 ± 12.20	62.8 ± 9.24	63.3 ± 10.3	61.3 ± 12.39	64.0 ± 11.23	62.7 ± 11.11
Gender [units: participants]
Female	39	32	41	41	44	197
Male	38	39	34	26	31	168

Outcome Measures

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1. Primary:

Sum of Pain Intensity Difference Over 48 Hours (SPID48) [ 48 hours ]

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Measure Type	Primary
Measure Title	Sum of Pain Intensity Difference Over 48 Hours (SPID48)
Measure Description	The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.
Time Frame	48 hours
Safety Issue	No

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.
Because the Sponsor terminated the study, the planned sample size was not reached in any treatment group, therefore, only a brief summary of an exploratory analysis of the primary efficacy variable (SPID48) is presented.

Reporting Groups

	Description
Tapentadol IR Fixed Dose 50 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol IR Fixed Dose 75 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol IR Fixed Dose 100 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Oxycodone HCL IR Fixed Dose 10 mg	oxycodone 10mg taken by mouth every 4-6 hours for 3 days
Placebo Fixed Dose	Matching placebo taken by mouth every 4-6 hours for 3 days

Measured Values

	Tapentadol IR Fixed Dose 50 mg	Tapentadol IR Fixed Dose 75 mg	Tapentadol IR Fixed Dose 100 mg	Oxycodone HCL IR Fixed Dose 10 mg	Placebo Fixed Dose
Number of Participants Analyzed [units: participants]	35	31	30	36	24
Sum of Pain Intensity Difference Over 48 Hours (SPID48) [units: score on a scale] Mean ± Standard Deviation	73.9 ± 123.89	54.4 ± 128.22	49.3 ± 136.92	57.6 ± 125.73	-18.6 ± 130.74

Statistical Analysis 1 for Sum of Pain Intensity Difference Over 48 Hours (SPID48)

Groups ^[1]	Tapentadol IR Fixed Dose 50 mg vs. Placebo Fixed Dose
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
LS mean difference of SPID48 ^[4]	91.4
95% Confidence Interval	( 49.77 to 133.07 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The study was terminated and did not reach the planned sample size.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Sum of Pain Intensity Difference Over 48 Hours (SPID48)

Groups ^[1]	Tapentadol IR Fixed Dose 75 mg vs. Placebo Fixed Dose
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
LS mean difference of SPID48 ^[4]	81.5
95% Confidence Interval	( 38.66 to 124.29 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The study was terminated and did not reach the planned sample size.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Sum of Pain Intensity Difference Over 48 Hours (SPID48)

Groups ^[1]	Tapentadol IR Fixed Dose 100 mg vs. Placebo Fixed Dose
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
LS mean difference of SPID48 ^[4]	81.5
95% Confidence Interval	( 39.21 to 123.80 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The study was terminated and did not reach the planned sample size.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Sum of Pain Intensity Difference Over 48 Hours (SPID48)

Groups ^[1]	Oxycodone HCL IR Fixed Dose 10 mg vs. Placebo Fixed Dose
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
LS mean difference of SPID48 ^[4]	82.4
95% Confidence Interval	( 38.96 to 125.88 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The study was terminated and did not reach the planned sample size.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

2. Secondary:

Time to First Rescue Pain Medication. [ 3 days ]

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3. Secondary:

The SPID at 12, 24, and 72 Hours Relative to First Dose. [ 3 days ]

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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. Restriction Description: A provision provides for 60 day prior review by sponsor extendable by 60 days to file a patent application and prior written consent of sponsor for disclosure of confidential information, if any.

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
Sponsor terminated study, sample size not reached. The protocol section describes 4 study arms defining the treatment groups in the study design. The participant flow module describes the 5 treatment groups analyzed for the primary endpoint

Results Point of Contact:

Name/Title: Senior Director, Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
phone: 609-730-6780

No publications provided

Responsible Party:	Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Senior Director, Clinical Leader )
Study ID Numbers:	CR011221, R331333PAI3001, KF5503/31
Study First Received:	August 11, 2006
Results First Received:	December 19, 2008
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00364533 History of Changes
Health Authority:	United States: Food and Drug Administration