Trial Outcomes & Findings for Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis (NCT NCT00771758)

NCT ID: NCT00771758

Last Updated: 2014-05-09

Results Overview

Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief. 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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 108 participants
• Primary outcome timeframe: 3 Days (72 hours)
• Results posted on: 2014-05-09

Participant Flow

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.

The study consisted of a screening/randomization period (one day) and a double blind active treatment period (10 days).

Participant milestones

Measure	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
Overall Study STARTED	44	43	21
Overall Study COMPLETED	36	31	19
Overall Study NOT COMPLETED	8	12	2

Reasons for withdrawal

Measure	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
Overall Study Adverse Event	2	8	1
Overall Study Lack of Efficacy	0	2	1
Overall Study Lost to Follow-up	1	0	0
Overall Study Protocol Violation	1	0	0
Overall Study Withdrawal by Subject	1	0	0
Overall Study Other	3	2	0

Baseline Characteristics

Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis

Baseline characteristics by cohort

Measure	Tapentadol IR n=44 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Total n=108 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	33 Participants n=4 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants	32 Participants n=7 Participants	14 Participants n=5 Participants	75 Participants n=4 Participants
Age, Continuous	69.8 years STANDARD_DEVIATION 12.28 • n=5 Participants	69.3 years STANDARD_DEVIATION 13.26 • n=7 Participants	69.6 years STANDARD_DEVIATION 12.36 • n=5 Participants	69.5 years STANDARD_DEVIATION 12.58 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	32 Participants n=7 Participants	14 Participants n=5 Participants	76 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	32 Participants n=4 Participants
Region of Enrollment USA	44 participants n=5 Participants	43 participants n=7 Participants	21 participants n=5 Participants	108 participants n=4 Participants

PRIMARY outcome

Timeframe: 3 Days (72 hours)

Population: The modified Intent-to-Treat(mITT) population was defined as all randomized patients who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.

Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.

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.

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Sum of Pain Intensity Difference Over 3 Days (SPID72)	139.0 Scores on a scale Standard Deviation 132.57	129.4 Scores on a scale Standard Deviation 115.76	114.2 Scores on a scale Standard Deviation 99.87	—	—	—

SECONDARY outcome

Timeframe: Day 3

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.

The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
30% Responder Rate on Day 3.	36.1 percentage of participants	39.0 percentage of participants	50.0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 3

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
50% Responder Rate on Day 3.	25.0 percentage of participants	24.4 percentage of participants	25.0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 5

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
30% Responder Rate on Day 5.	44.4 percentage of participants	48.8 percentage of participants	35.0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 5

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
50% Responder Rate on Day 5.	25.0 percentage of participants	26.8 percentage of participants	25.0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
30% Responder Rate on Day 10.	52.8 percentage of participants	39.0 percentage of participants	55.0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
50% Responder Rate on Day 10.	30.6 percentage of participants	26.8 percentage of participants	30.0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 2 Days (48 hours)

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Sum of Pain Intensity Difference Over 2 Days (SPID48)	82.1 Scores on a scale Standard Deviation 92.13	86.5 Scores on a scale Standard Deviation 69.46	67.1 Scores on a scale Standard Deviation 66.66	—	—	—

SECONDARY outcome

Timeframe: 5 Days (120 hours)

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID120 was calculated as the time-weighted Sum of PID scores over 120 hours. The range of SPID120 is from -1200 to 1200. The higher value in SPID indicates greater pain relief.

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Sum of Pain Intensity Difference Over 5 Days (SPID120)	252.7 Scores on a scale Standard Deviation 208.91	227.1 Scores on a scale Standard Deviation 200.66	198.4 Scores on a scale Standard Deviation 177.76	—	—	—

SECONDARY outcome

Timeframe: 10 Days (216 Hours)

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. Sum of Pain Intensity Difference Over 10 Days was calculated as the time-weighted Sum of PID scores up to Day 10, 8 AM. The range is from -2160 to 2160. The higher value in Sum of Pain Intensity Difference indicates greater pain relief.

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Sum of Pain Intensity Difference Over 10 Days	505.0 Scores on a scale Standard Deviation 373.00	422.9 Scores on a scale Standard Deviation 382.78	389.9 Scores on a scale Standard Deviation 343.31	—	—	—

SECONDARY outcome

Timeframe: 2 Days (48 Hours)

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Total Pain Relief (TOTPAR) Over 2 Days	84.7 Scores on a scale Standard Deviation 38.79	92.3 Scores on a scale Standard Deviation 42.42	89.5 Scores on a scale Standard Deviation 44.55	—	—	—

SECONDARY outcome

Timeframe: 3 Days (72 Hours)

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Total Pain Relief (TOTPAR) Over 3 Days	126.5 Scores on a scale Standard Deviation 57.98	138.3 Scores on a scale Standard Deviation 61.02	125.8 Scores on a scale Standard Deviation 66.12	—	—	—

SECONDARY outcome

Timeframe: 5 Days (120 Hours)

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 120. The range of TOTPAR over 5 days is from 0 to 480. A higher value in TOTPAR indicated greater pain relief.

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Total Pain Relief (TOTPAR) Over 5 Days	216.8 Scores on a scale Standard Deviation 97.36	232.6 Scores on a scale Standard Deviation 102.87	220.7 Scores on a scale Standard Deviation 106.00	—	—	—

SECONDARY outcome

Timeframe: 10 Days (216 Hours)

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 10, 8 AM. The range of TOTPAR over 10 days is from 0 to 864. A higher value in TOTPAR indicated greater pain relief.

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Total Pain Relief (TOTPAR) Over 10 Days	378.8 Scores on a scale Standard Deviation 167.27	414.4 Scores on a scale Standard Deviation 190.38	391.7 Scores on a scale Standard Deviation 184.35	—	—	—

SECONDARY outcome

Timeframe: 2 Days

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 2 Days	168.6 Scores on a scale Standard Deviation 109.56	178.9 Scores on a scale Standard Deviation 97.04	158.9 Scores on a scale Standard Deviation 87.52	—	—	—

SECONDARY outcome

Timeframe: 3 Days

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 3 Days	265.5 Scores on a scale Standard Deviation 162.13	267.7 Scores on a scale Standard Deviation 152.74	240.0 Scores on a scale Standard Deviation 130.29	—	—	—

SECONDARY outcome

Timeframe: 5 Days

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 5 days is from -1200 to 1680. A higher value in SPRID indicated greater pain relief.

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 5 Days	469.5 Scores on a scale Standard Deviation 270.72	459.7 Scores on a scale Standard Deviation 266.29	419.1 Scores on a scale Standard Deviation 229.41	—	—	—

SECONDARY outcome

Timeframe: 10 Days

Population: modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.

The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 10 days is from -2160 to 3024. A higher value in SPRID indicated greater pain relief.

Outcome measures

Measure	Tapentadol IR n=36 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=41 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=20 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 10 Days	883.8 Scores on a scale Standard Deviation 482.19	837.3 Scores on a scale Standard Deviation 509.07	781.7 Scores on a scale Standard Deviation 442.17	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-Treat subjects.

The participants were assessed whether were able to walk for 4 meters at each visit. For those subjects who were unable to walk 4 meters, the distance walked would be recorded. For those completed the walk, 4 meters were recorded. The change in distance walked at the end of study was derived using the distance walked at baseline minus the distance walked at the end of study (Day 10). The range of change in distance walked is from -4 to 4. A negative value indicated better performance.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Change From Baseline in Physical Performance: Measured Walk - Change in Distance Walked in the End of Study	-0.1 meters Standard Deviation 0.32	0.4 meters Standard Deviation 2.31	0.0 meters Standard Deviation 0.00	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-Treat subjects.

The time for the subject to walk for 4 meters was measured at baseline and the end of study. Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Change From Baseline in Physical Performance: Measured Walk - Change in Time Taken Per Meter to Take Walk in the End of Study	0.6 seconds Standard Deviation 2.10	3.5 seconds Standard Deviation 18.24	0.6 seconds Standard Deviation 1.72	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-Treat subjects.

The participants were assessed whether were able to rise from a chair 5 times at each visit. For those subjects who were unable to complete all 5 rises, the number of rises would be recorded. For those completed the 5 rises, 5 were recorded. The change in number of chair stands at the end of study was derived using the number of chair stands at baseline minus the number of chair stands at the end of study (Day 10). The range of change in number of chair stands is from -5 to 5. A negative value indicated better performance.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Change From Baseline in Physical Performance: Chair Stand - Change in Number of Chair Stands Completed in the End of Study	-0.1 chair stands Standard Deviation 0.23	-0.0 chair stands Standard Deviation 0.16	0.0 chair stands Standard Deviation 0.00	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-Treat subjects.

The time for the subject to rise from a chair 5 times was measured at baseline and the end of study.

Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Change From Baseline in Physical Performance: Chair Stand - Change in Time Taken to Complete Chair Stands in the End of Study	3.1 second Standard Deviation 9.51	3.6 second Standard Deviation 11.08	2.6 second Standard Deviation 9.22	—	—	—

SECONDARY outcome

Timeframe: Day 2

Population: Intent-to-Treat population.

Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Subject Satisfaction With Treatment on Day 2	3.5 Scores on a scale Standard Deviation 1.58	3.0 Scores on a scale Standard Deviation 1.69	3.6 Scores on a scale Standard Deviation 2.23	—	—	—

SECONDARY outcome

Timeframe: Day 3

Population: Intent-to-Treat population.

Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Subject Satisfaction With Treatment on Day 3	3.3 Scores on a scale Standard Deviation 1.69	2.8 Scores on a scale Standard Deviation 1.71	3.3 Scores on a scale Standard Deviation 1.70	—	—	—

SECONDARY outcome

Timeframe: Day 5

Population: Intent-to-Treat population.

Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Subject Satisfaction With Treatment on Day 5	3.5 Scores on a scale Standard Deviation 1.72	2.6 Scores on a scale Standard Deviation 1.27	3.7 Scores on a scale Standard Deviation 1.60	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-Treat population.

Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Subject Satisfaction With Treatment on Day 10	3.3 Scores on a scale Standard Deviation 1.94	2.5 Scores on a scale Standard Deviation 1.38	3.1 Scores on a scale Standard Deviation 1.61	—	—	—

SECONDARY outcome

Timeframe: 10 days

Population: Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.

Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was "Please rate the overall quality of your sleep last night.", which was administered via Interactive Voice Response (IVR) system in the morning.

Outcome measures

Measure	Tapentadol IR n=12 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=12 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=13 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study n=2 Participants Tapentadol IR	Missing - End of Study n=2 Participants Tapentadol IR	Baseline Total n=41 Participants Tapentadol IR
Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR) Good - Baseline	5 participants	4 participants	2 participants	0 participants	1 participants	12 participants
Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR) Missing - Baseline	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR) End of Study Total	12 participants	12 participants	13 participants	2 participants	2 participants	41 participants
Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR) Excellent - Baseline	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR) Fair - Baseline	2 participants	8 participants	8 participants	1 participants	0 participants	19 participants
Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR) Poor - Baseline	5 participants	0 participants	3 participants	1 participants	1 participants	10 participants

SECONDARY outcome

Timeframe: 10 days

Population: Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.

Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was "Please rate the overall quality of your sleep last night.", which was administered via IVR system in the morning.

Outcome measures

Measure	Tapentadol IR n=9 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=13 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=12 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study n=6 Participants Tapentadol IR	Missing - End of Study n=3 Participants Tapentadol IR	Baseline Total n=43 Participants Tapentadol IR
Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR) Excellent - Baseline	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR) Good - Baseline	1 participants	6 participants	2 participants	0 participants	1 participants	10 participants
Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR) Fair - Baseline	8 participants	6 participants	7 participants	3 participants	0 participants	24 participants
Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR) Poor - Baseline	0 participants	1 participants	3 participants	3 participants	1 participants	8 participants
Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR) Missing - Baseline	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants
Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR) End of Study Total	9 participants	13 participants	12 participants	6 participants	3 participants	43 participants

SECONDARY outcome

Timeframe: 10 days

Population: Placebo arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.

Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was "Please rate the overall quality of your sleep last night.", which was administered via IVR system in the morning.

Outcome measures

Measure	Tapentadol IR n=4 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=4 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=11 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study n=2 Participants Tapentadol IR	Missing - End of Study n=21 Participants Tapentadol IR	Baseline Total Tapentadol IR
Sleep Quality - Shift From Baseline to End of Study (Placebo) Fair - Baseline	1 participants	2 participants	6 participants	0 participants	9 participants	—
Sleep Quality - Shift From Baseline to End of Study (Placebo) Missing - Baseline	0 participants	0 participants	0 participants	0 participants	0 participants	—
Sleep Quality - Shift From Baseline to End of Study (Placebo) Excellent - Baseline	0 participants	0 participants	0 participants	0 participants	0 participants	—
Sleep Quality - Shift From Baseline to End of Study (Placebo) Good - Baseline	2 participants	0 participants	3 participants	0 participants	5 participants	—
Sleep Quality - Shift From Baseline to End of Study (Placebo) Poor - Baseline	1 participants	2 participants	2 participants	2 participants	7 participants	—
Sleep Quality - Shift From Baseline to End of Study (Placebo) End of Study Total	4 participants	4 participants	11 participants	2 participants	21 participants	—

SECONDARY outcome

Timeframe: Day 2

Population: Intent-to-Treat population.

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 2	14.7 percentage of participants	8.6 percentage of participants	11.1 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 3

Population: Intent-to-Treat population.

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 3	19.4 percentage of participants	13.9 percentage of participants	15.8 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 5

Population: Intent-to-Treat population.

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 5	25.0 percentage of participants	14.8 percentage of participants	11.1 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-Treat population.

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 10	28.6 percentage of participants	25.0 percentage of participants	7.1 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 2

Population: Intent-to-Treat population.

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 2	11.8 percentage of participants	14.3 percentage of participants	11.1 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 3

Population: Intent-to-Treat population.

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 3	16.7 percentage of participants	19.4 percentage of participants	10.5 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 5

Population: Intent-to-Treat population.

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 5	15.6 percentage of participants	14.8 percentage of participants	5.9 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-Treat population.

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 10	21.4 percentage of participants	20.8 percentage of participants	7.1 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 2

Population: Intent-to-Treat population.

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 2	20.6 percentage of participants	14.3 percentage of participants	0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 3

Population: Intent-to-Treat population.

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Functionality: Chair - Proportion With at Least 2 Point of Improvement From Baseline to Day 3	16.7 percentage of participants	8.3 percentage of participants	10.5 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 5

Population: Intent-to-Treat population.

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 5	18.8 percentage of participants	7.4 percentage of participants	5.6 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-Treat population.

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 10	28.6 percentage of participants	8.3 percentage of participants	14.3 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-Treat population.

Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Patient Global Impression of Change (PGIC) at End of Study Minimally improved	26.8 percenatage of participants	34.9 percenatage of participants	23.8 percenatage of participants	—	—	—
Patient Global Impression of Change (PGIC) at End of Study No change	26.8 percenatage of participants	11.6 percenatage of participants	28.6 percenatage of participants	—	—	—
Patient Global Impression of Change (PGIC) at End of Study Very much worse	0 percenatage of participants	0 percenatage of participants	4.8 percenatage of participants	—	—	—
Patient Global Impression of Change (PGIC) at End of Study Very much improved	17.1 percenatage of participants	9.3 percenatage of participants	9.5 percenatage of participants	—	—	—
Patient Global Impression of Change (PGIC) at End of Study Much improved	24.4 percenatage of participants	34.9 percenatage of participants	23.8 percenatage of participants	—	—	—
Patient Global Impression of Change (PGIC) at End of Study Minimally worse	0 percenatage of participants	4.7 percenatage of participants	4.8 percenatage of participants	—	—	—
Patient Global Impression of Change (PGIC) at End of Study Much worse	0 percenatage of participants	2.3 percenatage of participants	0 percenatage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-Treat population.

Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Clinician Global Impression of Change (CGIC) at End of Study Very much improved	19.5 percenatage of participants	7.0 percenatage of participants	14.3 percenatage of participants	—	—	—
Clinician Global Impression of Change (CGIC) at End of Study No change	26.8 percenatage of participants	9.3 percenatage of participants	19.0 percenatage of participants	—	—	—
Clinician Global Impression of Change (CGIC) at End of Study Minimally worse	0 percenatage of participants	4.7 percenatage of participants	4.8 percenatage of participants	—	—	—
Clinician Global Impression of Change (CGIC) at End of Study Much worse	0 percenatage of participants	2.3 percenatage of participants	0 percenatage of participants	—	—	—
Clinician Global Impression of Change (CGIC) at End of Study Very much worse	0 percenatage of participants	0 percenatage of participants	4.8 percenatage of participants	—	—	—
Clinician Global Impression of Change (CGIC) at End of Study Much improved	29.3 percenatage of participants	39.5 percenatage of participants	23.8 percenatage of participants	—	—	—
Clinician Global Impression of Change (CGIC) at End of Study Minimally improved	19.5 percenatage of participants	34.9 percenatage of participants	33.3 percenatage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to Treat population.

The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = "not at all" to 5="a very great deal."

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming Not at all	51.2 percent of participants	51.2 percent of participants	47.6 percent of participants	—	—	—
Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming A little bit	19.5 percent of participants	16.3 percent of participants	23.8 percent of participants	—	—	—
Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming Somewhat	12.2 percent of participants	16.3 percent of participants	19.0 percent of participants	—	—	—
Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming Quite a bit	12.2 percent of participants	9.3 percent of participants	4.8 percent of participants	—	—	—
Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming A great deal	2.4 percent of participants	4.7 percent of participants	4.8 percent of participants	—	—	—
Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming A very great deal	0 percent of participants	0 percent of participants	0 percent of participants	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to Treat population.

The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = "not at all" to 5="a very great deal."

Outcome measures

Measure	Tapentadol IR n=41 Participants 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 Participants 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 Participants 1 capsule every 4 - 6 hr as needed for up to 10 days	Poor - End of Study Tapentadol IR	Missing - End of Study Tapentadol IR	Baseline Total Tapentadol IR
Summary of Clinician Ease-of-Care at the End of Study: Bothersome A great deal	2.4 percent of participants	2.3 percent of participants	4.8 percent of participants	—	—	—
Summary of Clinician Ease-of-Care at the End of Study: Bothersome A very great deal	0 percent of participants	0 percent of participants	0 percent of participants	—	—	—
Summary of Clinician Ease-of-Care at the End of Study: Bothersome Not at all	56.1 percent of participants	53.5 percent of participants	76.2 percent of participants	—	—	—
Summary of Clinician Ease-of-Care at the End of Study: Bothersome A little bit	17.1 percent of participants	18.6 percent of participants	9.5 percent of participants	—	—	—
Summary of Clinician Ease-of-Care at the End of Study: Bothersome Somewhat	14.6 percent of participants	9.3 percent of participants	4.8 percent of participants	—	—	—
Summary of Clinician Ease-of-Care at the End of Study: Bothersome Quite a bit	7.3 percent of participants	14.0 percent of participants	4.8 percent of participants	—	—	—

Adverse Events

Tapentadol IR

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Oxycodone IR

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tapentadol IR n=44 participants at risk 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 participants at risk 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 participants at risk 1 capsule every 4 - 6 hr as needed for up to 10 days
Injury, poisoning and procedural complications Accidental Overdose	2.3% 1/44	0.00% 0/43	0.00% 0/21
Cardiac disorders Cardiac Failure Congestive	0.00% 0/44	2.3% 1/43	0.00% 0/21
Infections and infestations Cellulitis	0.00% 0/44	2.3% 1/43	0.00% 0/21

Other adverse events

Measure	Tapentadol IR n=44 participants at risk 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.	Oxycodone IR n=43 participants at risk 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.	Placebo n=21 participants at risk 1 capsule every 4 - 6 hr as needed for up to 10 days
Gastrointestinal disorders Nausea	34.1% 15/44	44.2% 19/43	4.8% 1/21
Gastrointestinal disorders Vomiting	27.3% 12/44	44.2% 19/43	19.0% 4/21
Gastrointestinal disorders Constipation	2.3% 1/44	7.0% 3/43	4.8% 1/21
Nervous system disorders Dizziness	18.2% 8/44	16.3% 7/43	0.00% 0/21
Nervous system disorders Headache	9.1% 4/44	4.7% 2/43	0.00% 0/21
Nervous system disorders Somnolence	9.1% 4/44	11.6% 5/43	9.5% 2/21
Metabolism and nutrition disorders Anorexia	2.3% 1/44	7.0% 3/43	4.8% 1/21
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/44	7.0% 3/43	0.00% 0/21

Additional Information

Senior Director of Clinical Development, Pain

Ortho-McNeil Janssen Scientific Affair, LLC.

Phone: (908)927-5465

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60