Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery - Study Results

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:	Postoperative Pain
Interventions:	Drug: Tapentadol IR Drug: Oxycodone IR

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 outpatient, multicenter US only study occurred between Jan. 14, 2009 and Mar. 19, 2010

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a screening period (up to 21 days) and a double-blind active treatment period (7 days, but can be up to 9 days).

	Tapentadol IR	Oxycodone IR
STARTED	194	188
COMPLETED	163	141
NOT COMPLETED	31	47
Adverse Event	6	15
Lack of Efficacy	18	25
Protocol Violation	2	0
Withdrawal by Subject	2	2
Unknown	1	3
Did Not Take Drug	2	2

Baseline Characteristics

Reporting Groups

	Description
Tapentadol IR	Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
Oxycodone IR	Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days

Baseline Measures

	Tapentadol IR	Oxycodone IR	Total
Number of Participants [units: participants]	192	186	378
Age ^[1] [units: participants]
<=18 years	4	6	10
Between 18 and 65 years	138	137	275
>=65 years	50	43	93
Age ^[2] [units: years] Mean ± Standard Deviation	53.2 ± 14.98	52.7 ± 14.97	52.9 ± 14.96
Gender ^[1] [units: participants]
Female	69	58	127
Male	123	128	251
Region of Enrollment ^[2] [units: participants]
USA	192	186	378

[1]	The summary statistics provided for baseline characteristic was based on safety population that includes 192 subjects in tapentadol group and 186 subjects in oxycodone group. The safety population includes randomized subjects took at least one dose of study drug.
[2]	The summary statistics provided for baseline characteristic was based on safety population that includes 192 subjects in tapentadol group and 186 subjects in oxycodone group. The safety population includes randomized subjects took at least one dose of study drug.

Outcome Measures

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1. Primary:

Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours) [ Time Frame: 3 Days (72 hours) ]

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2. Secondary:

Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline [ Time Frame: 7 Days ]

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3. Secondary:

Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline [ Time Frame: 7 Days ]

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4. Secondary:

Summary of 30% Responder Rate (With Imputation) on Day 3 [ Time Frame: Day 3 ]

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5. Secondary:

Summary of 30% Responder Rate (With Imputation) on Day 7 [ Time Frame: Day 7 ]

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6. Secondary:

Summary of 50% Responder Rate (With Imputation) on Day 3 [ Time Frame: Day 3 ]

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7. Secondary:

Summary of 50% Responder Rate (With Imputation) on Day 7 [ Time Frame: Day 7 ]

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8. Secondary:

Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours) [ Time Frame: 2 Days (48 hours) ]

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9. Secondary:

Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days [ Time Frame: 7 Days ]

Show Outcome Measure 9

10. Secondary:

Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours) [ Time Frame: 2 Days (48 hours) ]

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11. Secondary:

Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours) [ Time Frame: 3 Days (72hours) ]

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12. Secondary:

Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days [ Time Frame: 7 Days ]

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13. Secondary:

Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours) [ Time Frame: 2 Days (48 hours) ]

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14. Secondary:

Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours) [ Time Frame: 3 Days (72hours) ]

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15. Secondary:

Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days [ Time Frame: 7 Days ]

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16. Secondary:

Subject Satisfaction With Treatment [ Time Frame: 7 Days ]

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17. Secondary:

Patient Global Impression of Change (PGIC) at End of Study [ Time Frame: 7 Days ]

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18. Secondary:

Clinician Global Impression of Change (CGIC) at End of Study [ Time Frame: 7 Days ]

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19. Secondary:

Summary of Medical Resource Utilization – Number of Calls by the Subject to Study Site Personnel [ Time Frame: 7 Days ]

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20. Secondary:

Summary of Medical Resource Utilization – Number of Other Types of Contacts With Healthcare Professionals [ Time Frame: 7 Days ]

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21. Secondary:

Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) [ Time Frame: Baseline and 7 Days ]

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22. Secondary:

Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) [ Time Frame: Baseline and 7 Days ]

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23. Secondary:

Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) [ Time Frame: Baseline and 7 Days ]

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24. Secondary:

Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) [ Time Frame: Baseline and 7 Days ]

Show Outcome Measure 24

25. Secondary:

Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) [ Time Frame: Baseline and 7 Days ]

Show Outcome Measure 25

26. Secondary:

Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) [ Time Frame: Baseline and 7 Days ]

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27. Secondary:

Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) [ Time Frame: Baseline and 7 Days ]

Show Outcome Measure 27

28. Secondary:

Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) [ Time Frame: Baseline and 7 Days ]

Show Outcome Measure 28

29. Secondary:

Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) [ Time Frame: Baseline and 7 Days ]

Show Outcome Measure 29

30. Secondary:

Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) [ Time Frame: Baseline and 7 Days ]

Show Outcome Measure 30

31. Secondary:

Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) [ Time Frame: Baseline and 7 Days ]

Show Outcome Measure 31

32. Secondary:

Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) [ Time Frame: Baseline and 7 Days ]

Show Outcome Measure 32

33. Secondary:

Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR) [ Time Frame: Baseline and 7 Days ]

Show Outcome Measure 33

34. Secondary:

Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR) [ Time Frame: Baseline and 7 Days ]

Show Outcome Measure 34

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
No notable study limitations were identified by the Sponsor

Results Point of Contact:

Name/Title: Senior Director of Clinical Development, Pain
Organization: Ortho-McNeil Janssen Scientific Affair, LLC
phone: (908)927-5469
e-mail: GVorsang@its.jnj.com

No publications provided

Responsible Party:	Vice President, Medical Affairs Internal Medicine, Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:	NCT00814580 History of Changes
Other Study ID Numbers:	CR015040, R331333PAI3022, KF5503/49
Study First Received:	December 23, 2008
Results First Received:	March 10, 2011
Last Updated:	December 5, 2011
Health Authority:	United States: Food and Drug Administration