Trial Outcomes & Findings for NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain (NCT NCT00986180)

NCT ID: NCT00986180

Last Updated: 2012-12-19

Results Overview

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 667 participants
• Primary outcome timeframe: 0 hour (prior to first dose) and 120 hours
• Results posted on: 2012-12-19

Participant Flow

19 subjects either did not take medication or did not have verifiable drug exposure. 2 subjects were randomized in two different sites, information was included for only one site. 1 subject was randomized in error.

Participant milestones

Measure	NUCYNTA 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Overall Study STARTED	321	324
Overall Study COMPLETED	277	268
Overall Study NOT COMPLETED	44	56

Reasons for withdrawal

Measure	NUCYNTA 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Overall Study Adverse Event	21	23
Overall Study Lack of Efficacy	4	3
Overall Study Lost to Follow-up	5	7
Overall Study Physician Decision	1	3
Overall Study Protocol Violation	2	0
Overall Study Withdrawal by Subject	1	9
Overall Study Miscellanies	10	11

Baseline Characteristics

NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain

Baseline characteristics by cohort

Measure	NUCYNTA n=321 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=324 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg	Total n=645 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	282 Participants n=5 Participants	297 Participants n=7 Participants	579 Participants n=5 Participants
Age, Categorical >=65 years	39 Participants n=5 Participants	26 Participants n=7 Participants	65 Participants n=5 Participants
Age Continuous	45.7 years STANDARD_DEVIATION 14.18 • n=5 Participants	45.1 years STANDARD_DEVIATION 14.36 • n=7 Participants	45.4 years STANDARD_DEVIATION 14.26 • n=5 Participants
Sex: Female, Male Female	145 Participants n=5 Participants	176 Participants n=7 Participants	321 Participants n=5 Participants
Sex: Female, Male Male	176 Participants n=5 Participants	148 Participants n=7 Participants	324 Participants n=5 Participants
Region of Enrollment UNITED STATES	321 participants n=5 Participants	324 participants n=7 Participants	645 participants n=5 Participants
Baseline Low Back Pain Intensity	7.2 Units on a scale STANDARD_DEVIATION 1.66 • n=5 Participants	7.2 Units on a scale STANDARD_DEVIATION 1.54 • n=7 Participants	7.2 Units on a scale STANDARD_DEVIATION 1.60 • n=5 Participants
Baseline Index Leg Pain Intensity	6.2 Units on a scale STANDARD_DEVIATION 2.21 • n=5 Participants	6.2 Units on a scale STANDARD_DEVIATION 2.10 • n=7 Participants	6.2 Units on a scale STANDARD_DEVIATION 2.15 • n=5 Participants
Ethnicity Hispanic or Latino	43 participants n=5 Participants	39 participants n=7 Participants	82 participants n=5 Participants
Ethnicity Not Hispanic or Latino	278 participants n=5 Participants	283 participants n=7 Participants	561 participants n=5 Participants
Ethnicity Not Reported	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Baseline BMI	30.9 kg/m^2 STANDARD_DEVIATION 8.83 • n=5 Participants	30.4 kg/m^2 STANDARD_DEVIATION 8.63 • n=7 Participants	30.6 kg/m^2 STANDARD_DEVIATION 8.72 • n=5 Participants

PRIMARY outcome

Timeframe: 0 hour (prior to first dose) and 120 hours

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation)	264.6 Units on a scale Standard Error 11.43	264.0 Units on a scale Standard Error 11.22

SECONDARY outcome

Timeframe: Day 0 and Day 2

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation)	80.1 Units on a Scale Standard Error 4.34	81.8 Units on a Scale Standard Error 4.26

SECONDARY outcome

Timeframe: Day 0 and Day 3

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation)	137.2 Units on a scale Standard Error 6.60	138.1 Units on a scale Standard Error 6.47

SECONDARY outcome

Timeframe: Day 0 and Day 10

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation)	540.2 Units on a scale Standard Error 21.23	538.6 Units on a scale Standard Error 20.84

SECONDARY outcome

Timeframe: Day 0 and Day 2

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation)	73.6 Units on a Scale Standard Error 4.34	72.1 Units on a Scale Standard Error 4.26

SECONDARY outcome

Timeframe: Day 0 and Day 3

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation)	125.5 Units on a Scale Standard Error 6.63	123.0 Units on a Scale Standard Error 6.51

SECONDARY outcome

Timeframe: Day 0 and Day 5

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 5 days.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation)	239.2 Units on a Scale Standard Error 11.29	234.1 Units on a Scale Standard Error 11.08

SECONDARY outcome

Timeframe: Day 0 and Day 10

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation)	488.0 Units on a Scale Standard Error 20.71	476.4 Units on a Scale Standard Error 20.33

SECONDARY outcome

Timeframe: Day 0 and Day 5

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Pain Relief - 5-Point Numerical Rating Scale, 0=None, 4=Complete. Total Pain Relief (TOTPAR) is a weighted sum of pain relieve over a specified time period, say 5 days.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days	254.8 Units on a Scale Standard Error 5.01	256.4 Units on a Scale Standard Error 4.91

SECONDARY outcome

Timeframe: Day 0 and Day 5

Population: Intent-To-Treat Population (all randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain) and have both baseline and Day 5 SF-MPQ-2 measurement

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.

Outcome measures

Measure	NUCYNTA n=274 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=276 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5	-2.4 Units on a Scale Standard Deviation 2.05	-2.4 Units on a Scale Standard Deviation 2.14

SECONDARY outcome

Timeframe: Day 0 and Day 10

Population: Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.

Outcome measures

Measure	NUCYNTA n=289 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit	-3.1 Units on a Scale Standard Deviation 2.35	-2.9 Units on a Scale Standard Deviation 2.31

SECONDARY outcome

Timeframe: Day 0 and Day 5

Population: Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.

Outcome measures

Measure	NUCYNTA n=274 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=276 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5	-2.6 Units on a Scale Standard Deviation 2.23	-2.5 Units on a Scale Standard Deviation 2.09

SECONDARY outcome

Timeframe: Day 0 and Day 10

Population: Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.

Outcome measures

Measure	NUCYNTA n=289 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit	-3.3 Units on a Scale Standard Deviation 2.46	-3.2 Units on a Scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: Day 0 and Day 5

Population: Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or "pins and needles" and numbness.

Outcome measures

Measure	NUCYNTA n=274 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=276 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5	-1.5 Units on a Scale Standard Deviation 1.92	-1.4 Units on a Scale Standard Deviation 1.85

SECONDARY outcome

Timeframe: Day 0 and Day 10

Population: Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or "pins and needles" and numbness.

Outcome measures

Measure	NUCYNTA n=289 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit	-1.8 Units on a Scale Standard Deviation 1.94	-1.6 Units on a Scale Standard Deviation 1.99

SECONDARY outcome

Timeframe: Day 0 and Day 5

Population: Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.

Outcome measures

Measure	NUCYNTA n=274 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=276 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5	-2.0 score of scale Standard Deviation 2.46	-1.9 score of scale Standard Deviation 2.31

SECONDARY outcome

Timeframe: Day 0 and Day 10

Population: Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.

Outcome measures

Measure	NUCYNTA n=289 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit	-2.4 Units on a Scale Standard Deviation 2.74	-2.2 Units on a Scale Standard Deviation 2.39

SECONDARY outcome

Timeframe: Day 0 and Day 5

Population: Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.

Outcome measures

Measure	NUCYNTA n=275 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=277 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5	-2.2 Units on a Scale Standard Deviation 1.84	-2.1 Units on a Scale Standard Deviation 1.74

SECONDARY outcome

Timeframe: Day 0 and Day 10

Population: Intent-To-Treat Population with both baseline and Day 10 SF-MPQ-2 measurements.

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.

Outcome measures

Measure	NUCYNTA n=290 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit	-2.7 Units on a Scale Standard Deviation 2.04	-2.5 Units on a Scale Standard Deviation 1.91

SECONDARY outcome

Timeframe: Day 0 and Day 10/last visit

Population: Intent-To-Treat Population.

Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).

Outcome measures

Measure	NUCYNTA n=302 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=311 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Patient Global Impression of Change at End of Study 1 = Very much improved	89 Units on a Scale	90 Units on a Scale
Patient Global Impression of Change at End of Study 2 = Much improved	111 Units on a Scale	116 Units on a Scale
Patient Global Impression of Change at End of Study 3 = Minimally improved	59 Units on a Scale	67 Units on a Scale
Patient Global Impression of Change at End of Study Missing	12 Units on a Scale	13 Units on a Scale
Patient Global Impression of Change at End of Study 4 = No change	27 Units on a Scale	24 Units on a Scale
Patient Global Impression of Change at End of Study 5 = Minimally worse	2 Units on a Scale	0 Units on a Scale
Patient Global Impression of Change at End of Study 6 = Much worse	1 Units on a Scale	0 Units on a Scale
Patient Global Impression of Change at End of Study 7 = Very much worse	1 Units on a Scale	1 Units on a Scale

SECONDARY outcome

Timeframe: Day 0 and Day 10/lst visit

Population: Intent-To-Treat Population with PGIC assessment.

Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).

Outcome measures

Measure	NUCYNTA n=290 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Patient Global Impression of Change at End of Study	2.1 Units on a Scale Standard Deviation 1.04	2.1 Units on a Scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: Day 0 and Day 10/last visit

Population: Intent-To-Treat Population.

Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).

Outcome measures

Measure	NUCYNTA n=302 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=311 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Clinician Global Impression of Change at End of Study 1 = Very much improved	78 Units on a Scale	77 Units on a Scale
Clinician Global Impression of Change at End of Study 2 = Much improved	127 Units on a Scale	130 Units on a Scale
Clinician Global Impression of Change at End of Study 3 = Minimally improved	60 Units on a Scale	70 Units on a Scale
Clinician Global Impression of Change at End of Study 4 = No change	21 Units on a Scale	18 Units on a Scale
Clinician Global Impression of Change at End of Study 5 = Minimally worse	2 Units on a Scale	1 Units on a Scale
Clinician Global Impression of Change at End of Study 6 = Much worse	1 Units on a Scale	0 Units on a Scale
Clinician Global Impression of Change at End of Study 7 = Very much worse	2 Units on a Scale	0 Units on a Scale
Clinician Global Impression of Change at End of Study Missing	12 Units on a Scale	13 Units on a Scale

SECONDARY outcome

Timeframe: Day 0 and Day 10/last visit

Population: Intent-To-Treat Population with CGIC assessment.

Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).

Outcome measures

Measure	NUCYNTA n=290 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Clinician Global Impression of Change at End of Study	2.1 Units on a Scale Standard Deviation 0.99	2.1 Units on a Scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: Day 0 and Day 5

Population: Intent-To-Treat Population.

The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).

Outcome measures

Measure	NUCYNTA n=302 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=311 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Satisfaction With Treatment at Day 5 4 = Neither satisfied nor dissatisfied	16 Units on a Scale	5 Units on a Scale
Satisfaction With Treatment at Day 5 5 = Slightly dissatisfied	8 Units on a Scale	7 Units on a Scale
Satisfaction With Treatment at Day 5 6 = Somewhat dissatisfied	2 Units on a Scale	5 Units on a Scale
Satisfaction With Treatment at Day 5 7 = Very dissatisfied	3 Units on a Scale	4 Units on a Scale
Satisfaction With Treatment at Day 5 Missing	27 Units on a Scale	34 Units on a Scale
Satisfaction With Treatment at Day 5 1 = Very satisfied	113 Units on a Scale	92 Units on a Scale
Satisfaction With Treatment at Day 5 2 = Somewhat satisfied	102 Units on a Scale	132 Units on a Scale
Satisfaction With Treatment at Day 5 3 = Slightly satisfied	31 Units on a Scale	32 Units on a Scale

SECONDARY outcome

Timeframe: Day 0 and Day 5

Population: Intent-To-Treat Population with subject's satisfaction assessment on Day 5.

The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).

Outcome measures

Measure	NUCYNTA n=275 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=277 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Satisfaction With Treatment at Day 5	2.0 Units on a Scale Standard Deviation 1.19	2.0 Units on a Scale Standard Deviation 1.18

SECONDARY outcome

Timeframe: Day 0 and Day 10/last visit

Population: Intent-To-Treat Population.

The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).

Outcome measures

Measure	NUCYNTA n=302 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=311 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Satisfaction With Treatment at End of Study 5 = Slightly dissatisfied	7 Units on a Scale	3 Units on a Scale
Satisfaction With Treatment at End of Study 6 = Somewhat dissatisfied	8 Units on a Scale	4 Units on a Scale
Satisfaction With Treatment at End of Study 7 = Very dissatisfied	10 Units on a Scale	13 Units on a Scale
Satisfaction With Treatment at End of Study Missing	12 Units on a Scale	13 Units on a Scale
Satisfaction With Treatment at End of Study 1 = Very satisfied	146 Units on a Scale	148 Units on a Scale
Satisfaction With Treatment at End of Study 2 = Somewhat satisfied	84 Units on a Scale	87 Units on a Scale
Satisfaction With Treatment at End of Study 3 = Slightly satisfied	28 Units on a Scale	29 Units on a Scale
Satisfaction With Treatment at End of Study 4 = Neither satisfied nor dissatisfied	7 Units on a Scale	14 Units on a Scale

SECONDARY outcome

Timeframe: Day 0 and Day 10/last visit

Population: Intent-To-Treat Population with subject's satisfaction assessment at end of the study.

The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).

Outcome measures

Measure	NUCYNTA n=290 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Satisfaction With Treatment at End of Study	2.0 Units on a Scale Standard Deviation 1.49	2.0 Units on a Scale Standard Deviation 1.48

SECONDARY outcome

Timeframe: Day 0 and Day 5

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Number of subjects had ≥ 30% reduction from baseline in low back pain intensity without nausea or vomiting reported.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Incidence of 30% Responders Without Nausea or Vomiting at Day 5	117 Participants	104 Participants

SECONDARY outcome

Timeframe: Day 0 and Day 5

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

Number of subjects had ≥ 50% reduction from baseline in low back pain intensity without nausea or vomiting reported.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Incidence of 50% Responders Without Nausea or Vomiting at Day 5	72 Participants	60 Participants

SECONDARY outcome

Timeframe: Day 0 and Day 10/last visit

Population: Safety Population: all randomized subjects who take at least 1 dose of study drug.

Outcome measures

Measure	NUCYNTA n=321 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=324 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Number of subjects with adverse events	21 Participants	26 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Eye disorders	1 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Back pain	1 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Muscle spasms	1 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Vision blurred	1 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Gastrointestinal disorders	11 Participants	14 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Nausea	6 Participants	9 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Vomiting	5 Participants	6 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Diarrhea	1 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Abdominal discomfort	1 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Constipation	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation General disorders and admin. site conditions	2 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Fatigue	2 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Infections and infestations	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Upper respiratory tract infection	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Injury, poisoning and procedural complications	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Contusion	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Investigations	1 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Hepatic enzyme increased	1 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Liver function test abnormal	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Musculoskeletal and connective tissue disorders	2 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Neoplasms benign, malignant and unspecified	1 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Lung cancer metastatic	1 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Nervous system disorders	6 Participants	9 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Dizziness	3 Participants	3 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Somnolence	2 Participants	2 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Headache	1 Participants	2 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Convulsion	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Syncope	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Psychiatric disorders	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Depression	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Skin and subcutaneous tissue disorders	1 Participants	3 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Rash	0 Participants	2 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Pruritus	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation Rash generalized	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 0 and Day 10/last visit

Population: Safety Population: all randomized subjects who take at least 1 dose of study drug.

Number of subjects that reported nausea as a treatment-emergent adverse event during the study.

Outcome measures

Measure	NUCYNTA n=321 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=324 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event	51 Participants	67 Participants

SECONDARY outcome

Timeframe: Day 0 and Day 10/last visit

Population: Safety Population: all randomized subjects who take at least 1 dose of study drug.

Number of subjects that reported vomiting as a treatment emergent adverse event during the study.

Outcome measures

Measure	NUCYNTA n=321 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=324 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event	51 Participants	80 Participants

SECONDARY outcome

Timeframe: Day 0 and Day 10/last visit

Population: Safety Population: all randomized subjects who take at least 1 dose of study drug.

Number of subjects that reported constipation as a treatment emergent adverse event during the study.

Outcome measures

Measure	NUCYNTA n=321 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=324 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event	7 Participants	23 Participants

SECONDARY outcome

Timeframe: Day 0 and Day 10/last visit

Population: Safety Population: all randomized subjects who take at least 1 dose of study drug.

Number of subjects that reported pruritus as a treatment emergent adverse event during the study.

Outcome measures

Measure	NUCYNTA n=321 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=324 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event	27 Participants	26 Participants

SECONDARY outcome

Timeframe: Day 0 and Day 10/last visit

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

30% response means >= 30% reduction from baseline in low back pain intensity score.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain	42.93 Hours Interval 33.83 to 48.97	44.27 Hours Interval 30.72 to 54.97

SECONDARY outcome

Timeframe: Day 0 and Day 10/last visit

Population: Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).

50% response means >= 50% reduction from baseline in low back pain intensity score.

Outcome measures

Measure	NUCYNTA n=287 Participants 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=298 Participants 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain	92.05 Hours Interval 71.93 to 107.92	107.45 Hours Interval 78.65 to 127.38

Adverse Events

NUCYNTA

Serious events: 2 serious events

Other events: 141 other events

Deaths: 0 deaths

Oxycodone IR

Serious events: 3 serious events

Other events: 165 other events

Deaths: 0 deaths

Serious adverse events

Measure	NUCYNTA n=321 participants at risk 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=324 participants at risk 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Musculoskeletal and connective tissue disorders Back Pain	0.31% 1/321	0.00% 0/324
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Metastatic	0.31% 1/321	0.00% 0/324
Nervous system disorders Convulsion	0.00% 0/321	0.31% 1/324
Nervous system disorders Syncope	0.00% 0/321	0.31% 1/324
Psychiatric disorders Anxiety	0.00% 0/321	0.31% 1/324

Other adverse events

Measure	NUCYNTA n=321 participants at risk 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg	Oxycodone IR n=324 participants at risk 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
Gastrointestinal disorders Nausea	15.9% 51/321	20.7% 67/324
Gastrointestinal disorders Vomiting	15.9% 51/321	24.7% 80/324
Gastrointestinal disorders Constipation	2.2% 7/321	7.1% 23/324
Nervous system disorders Dizziness	11.8% 38/321	10.5% 34/324
Nervous system disorders Somnolence	8.1% 26/321	6.8% 22/324
Nervous system disorders Headache	4.4% 14/321	6.2% 20/324
Skin and subcutaneous tissue disorders Pruritus	8.4% 27/321	8.0% 26/324

Additional Information

Vice President, Medical Affairs, Internal Medicine

Janssen Pharmaceuticals

Phone: 1 908 218-7250

Results disclosure agreements

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

Restriction type: GT60