Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis - 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:	Back Pain
Interventions:	Drug: oxycodone IR Drug: placebo Drug: tapentadol IR

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 outpatient, multicenter study occurred between August 28, 2008 and December 9, 2009. The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects.

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 study occurred between August 28, 2008 and December 9, 2009.

The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects.

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/randomization period (one day) and a double blind active treatment period (10 days).

Reporting Groups

	Description
Tapentadol IR	50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
Oxycodone IR	5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
Placebo	1 capsule every 4 - 6 hr as needed for up to 10 days

Participant Flow: Overall Study

	Tapentadol IR	Oxycodone IR	Placebo
STARTED	44	43	21
COMPLETED	36	31	19
NOT COMPLETED	8	12	2
Adverse Event	2	8	1
Lack of Efficacy	0	2	1
Lost to Follow-up	1	0	0
Protocol Violation	1	0	0
Withdrawal by Subject	1	0	0
Other	3	2	0

Baseline Characteristics

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Reporting Groups

	Description
Tapentadol IR	50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
Oxycodone IR	5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
Placebo	1 capsule every 4 - 6 hr as needed for up to 10 days

Baseline Measures

	Tapentadol IR	Oxycodone IR	Placebo	Total
Number of Participants [units: participants]	44	43	21	108
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	15	11	7	33
>=65 years	29	32	14	75
Age [units: years] Mean ± Standard Deviation	69.8 ± 12.28	69.3 ± 13.26	69.6 ± 12.36	69.5 ± 12.58
Gender [units: participants]
Female	30	32	14	76
Male	14	11	7	32
Region of Enrollment [units: participants]
USA	44	43	21	108

Outcome Measures

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1. Primary:

Sum of Pain Intensity Difference Over 3 Days (SPID72) [ Time Frame: 3 Days (72 hours) ]

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2. Secondary:

30% Responder Rate on Day 3. [ Time Frame: Day 3 ]

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3. Secondary:

50% Responder Rate on Day 3. [ Time Frame: Day 3 ]

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4. Secondary:

30% Responder Rate on Day 5. [ Time Frame: Day 5 ]

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5. Secondary:

50% Responder Rate on Day 5. [ Time Frame: Day 5 ]

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6. Secondary:

30% Responder Rate on Day 10. [ Time Frame: Day 10 ]

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7. Secondary:

50% Responder Rate on Day 10. [ Time Frame: Day 10 ]

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8. Secondary:

Sum of Pain Intensity Difference Over 2 Days (SPID48) [ Time Frame: 2 Days (48 hours) ]

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9. Secondary:

Sum of Pain Intensity Difference Over 5 Days (SPID120) [ Time Frame: 5 Days (120 hours) ]

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10. Secondary:

Sum of Pain Intensity Difference Over 10 Days [ Time Frame: 10 Days (216 Hours) ]

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11. Secondary:

Total Pain Relief (TOTPAR) Over 2 Days [ Time Frame: 2 Days (48 Hours) ]

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12. Secondary:

Total Pain Relief (TOTPAR) Over 3 Days [ Time Frame: 3 Days (72 Hours) ]

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13. Secondary:

Total Pain Relief (TOTPAR) Over 5 Days [ Time Frame: 5 Days (120 Hours) ]

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14. Secondary:

Total Pain Relief (TOTPAR) Over 10 Days [ Time Frame: 10 Days (216 Hours) ]

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15. Secondary:

Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 2 Days [ Time Frame: 2 Days ]

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16. Secondary:

Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 3 Days [ Time Frame: 3 Days ]

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17. Secondary:

Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 5 Days [ Time Frame: 5 Days ]

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18. Secondary:

Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 10 Days [ Time Frame: 10 Days ]

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19. Secondary:

Change From Baseline in Physical Performance: Measured Walk - Change in Distance Walked in the End of Study [ Time Frame: Day 10 ]

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20. Secondary:

Change From Baseline in Physical Performance: Measured Walk - Change in Time Taken Per Meter to Take Walk in the End of Study [ Time Frame: Day 10 ]

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21. Secondary:

Change From Baseline in Physical Performance: Chair Stand - Change in Number of Chair Stands Completed in the End of Study [ Time Frame: Day 10 ]

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22. Secondary:

Change From Baseline in Physical Performance: Chair Stand - Change in Time Taken to Complete Chair Stands in the End of Study [ Time Frame: Day 10 ]

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23. Secondary:

Summary of Subject Satisfaction With Treatment on Day 2 [ Time Frame: Day 2 ]

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24. Secondary:

Summary of Subject Satisfaction With Treatment on Day 3 [ Time Frame: Day 3 ]

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25. Secondary:

Summary of Subject Satisfaction With Treatment on Day 5 [ Time Frame: Day 5 ]

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26. Secondary:

Summary of Subject Satisfaction With Treatment on Day 10 [ Time Frame: Day 10 ]

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27. Secondary:

Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR) [ Time Frame: 10 days ]

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28. Secondary:

Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR) [ Time Frame: 10 days ]

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29. Secondary:

Sleep Quality - Shift From Baseline to End of Study (Placebo) [ Time Frame: 10 days ]

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30. Secondary:

Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 2 [ Time Frame: Day 2 ]

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31. Secondary:

Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 3 [ Time Frame: Day 3 ]

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32. Secondary:

Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 5 [ Time Frame: Day 5 ]

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33. Secondary:

Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 10 [ Time Frame: Day 10 ]

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34. Secondary:

Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 2 [ Time Frame: Day 2 ]

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35. Secondary:

Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 3 [ Time Frame: Day 3 ]

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36. Secondary:

Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 5 [ Time Frame: Day 5 ]

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37. Secondary:

Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 10 [ Time Frame: Day 10 ]

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38. Secondary:

Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 2 [ Time Frame: Day 2 ]

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39. Secondary:

Summary of Functionality: Chair - Proportion With at Least 2 Point of Improvement From Baseline to Day 3 [ Time Frame: Day 3 ]

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40. Secondary:

Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 5 [ Time Frame: Day 5 ]

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41. Secondary:

Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 10 [ Time Frame: Day 10 ]

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42. Secondary:

Patient Global Impression of Change (PGIC) at End of Study [ Time Frame: Day 10 ]

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43. Secondary:

Clinician Global Impression of Change (CGIC) at End of Study [ Time Frame: Day 10 ]

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44. Secondary:

Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming [ Time Frame: Day 10 ]

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45. Secondary:

Summary of Clinician Ease-of-Care at the End of Study: Bothersome [ Time Frame: Day 10 ]

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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
Insufficient number of participants enrolled to meet proposed sample size, so that statistical inferences could not be made.

Results Point of Contact:

Name/Title: Senior Director of Clinical Development, Pain
Organization: Ortho-McNeil Janssen Scientific Affair, LLC.
phone: (908)927-5465

No publications provided

Responsible Party:	Senior Director, Clinical Development, Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:	NCT00771758 History of Changes
Other Study ID Numbers:	CR015064, KF5503/40
Study First Received:	October 10, 2008
Results First Received:	December 8, 2010
Last Updated:	March 10, 2011
Health Authority:	United States: Food and Drug Administration