Trial Outcomes & Findings for Phase 2 Study of Tapentadol Prolonged Release in Cancer Pain Participants (NCT NCT00805142)

Last Updated: 2013-07-29

Results Overview

Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

Day 15 up to Day 19

Results posted on

2013-07-29

Participant Flow

95 participants signed the informed consent form, of which 78 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	Opioid-Naive Participants (Tapentadol PR) Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants (Tapentadol PR) Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release \[SR\] preparation, oxycodone hydrochloride \[HCl\] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
Titration Period STARTED	36	42
Titration Period COMPLETED	30	32
Titration Period NOT COMPLETED	6	10
Maintenance Period STARTED	30	32
Maintenance Period COMPLETED	30	30
Maintenance Period NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Opioid-Naive Participants (Tapentadol PR) Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants (Tapentadol PR) Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release \[SR\] preparation, oxycodone hydrochloride \[HCl\] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
Titration Period Adverse Event	3	3
Titration Period Lack of Efficacy	1	1
Titration Period Lost to Follow-up	0	1
Titration Period Disease Progression	2	1
Titration Period Withdrawal of consent	0	1
Titration Period Other	0	3
Maintenance Period Adverse Event	0	1
Maintenance Period Other	0	1

Baseline Characteristics

Phase 2 Study of Tapentadol Prolonged Release in Cancer Pain Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Opioid-Naive Participants (Tapentadol PR) n=30 Participants Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants (Tapentadol PR) n=36 Participants Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release \[SR\] preparation, oxycodone hydrochloride \[HCl\] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.	Total n=66 Participants Total of all reporting groups
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Age Continuous	71.7 years STANDARD_DEVIATION 9.97 • n=5 Participants	70.0 years STANDARD_DEVIATION 8.44 • n=7 Participants	70.7 years STANDARD_DEVIATION 9.14 • n=5 Participants

PRIMARY outcome

Timeframe: Day 15 up to Day 19

Population: Per protocol set (PPS) included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.

Outcome measures

Outcome measures
Measure	Opioid-Naive Participants Maintenance Period (Tapentadol PR) n=29 Participants Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants Maintenance Period (Tapentadol PR) n=28 Participants Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase	89.7 percentage of participants Interval 72.6 to 97.8	92.9 percentage of participants Interval 76.5 to 99.1

SECONDARY outcome

Timeframe: Day 3 up to Day 14

Population: The PPS included all participants enrolled excluding those with a major protocol violation.

Percentage of participants who achieved dose adjustment included those participants whose dose was adjusted during the titration period period and entered the fixed dose maintenance period. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period.

Outcome measures

Outcome measures
Measure	Opioid-Naive Participants Maintenance Period (Tapentadol PR) n=30 Participants Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants Maintenance Period (Tapentadol PR) n=36 Participants Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
Percentage of Participants Who Achieve Dose Adjustment	93.3 percentage of participants Interval 77.9 to 99.2	80.6 percentage of participants Interval 64.0 to 91.8

SECONDARY outcome

Timeframe: Baseline (Average of Day -1 and Day 0 morning scores), Day 20

Population: The PPS included all participants enrolled excluding those with a major protocol violation.

Pain intensity scores were measured on 11 point NRS, where 0 = no pain and 10 = severest pain imaginable. The pain intensity at Baseline was the average of scores on two consecutive morning doses (Day -1 and Day 0) and on Day 20 only a single observation was recorded.

Outcome measures

Outcome measures
Measure	Opioid-Naive Participants Maintenance Period (Tapentadol PR) n=30 Participants Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants Maintenance Period (Tapentadol PR) n=36 Participants Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale Baseline	4.9 units on a scale Standard Deviation 1.40	1.3 units on a scale Standard Deviation 1.30
Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale Day 20	2.4 units on a scale Standard Deviation 1.22	1.7 units on a scale Standard Deviation 1.74

SECONDARY outcome

Timeframe: Baseline and Day 19

Population: The PPS included all participants enrolled excluding those with a major protocol violation. Missing values were imputed using last observed carried forward (LOCF) method.

Pain VAS assesses the pain intensity experienced by the participant on a 100 millimeter (mm) VAS, where responses range from a response of no pain (score of 0 mm) to severest pain imaginable (score of 100 mm). The participant indicated the pain by marking the applicable place with slash (/) and the investigator then measured the length from left edge to the slash.

Outcome measures

Outcome measures
Measure	Opioid-Naive Participants Maintenance Period (Tapentadol PR) n=30 Participants Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants Maintenance Period (Tapentadol PR) n=36 Participants Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
Pain Assessment Using Visual Analog Scale (VAS) Score Baseline	44.34 mm Standard Deviation 12.870	10.71 mm Standard Deviation 11.623
Pain Assessment Using Visual Analog Scale (VAS) Score Day 19	20.33 mm Standard Deviation 10.874	10.30 mm Standard Deviation 11.098

SECONDARY outcome

Timeframe: Day 12, 13, 14, 15, 16, 17, 18 and 19

Population: The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.

The immediate release (IR) oral opioids were used as rescue doses in the participants with lack of efficacy or to have relief from severe pain. In case of opioid-switching participants rescue doses were continued without any change in the preceding doses or the type throughout the study. The IR morphine HCl was used as the rescue dose for opioid-naive participants. The upper limit of rescue doses was specified for each daily dose of tapentadol PR. There was no change in the dose of rescue medication during maintenance period for opioid-naive participants.

Outcome measures

Outcome measures
Measure	Opioid-Naive Participants Maintenance Period (Tapentadol PR) n=29 Participants Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants Maintenance Period (Tapentadol PR) n=28 Participants Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
Rescue Doses Day 12	0.34 mg per day Standard Deviation 1.289	1.07 mg per day Standard Deviation 2.562
Rescue Doses Day 13	0.52 mg per day Standard Deviation 1.550	1.16 mg per day Standard Deviation 2.380
Rescue Doses Day 14	1.03 mg per day Standard Deviation 2.061	1.61 mg per day Standard Deviation 3.400
Rescue Doses Day 15	1.21 mg per day Standard Deviation 3.178	2.05 mg per day Standard Deviation 4.503
Rescue Doses Day 16	1.72 mg per day Standard Deviation 3.348	1.21 mg per day Standard Deviation 2.795
Rescue Doses Day 17	1.72 mg per day Standard Deviation 3.605	1.56 mg per day Standard Deviation 3.513
Rescue Doses Day 18	0.86 mg per day Standard Deviation 1.922	2.32 mg per day Standard Deviation 5.639
Rescue Doses Day 19	1.03 mg per day Standard Deviation 2.061	1.96 mg per day Standard Deviation 4.200

SECONDARY outcome

Timeframe: Baseline up to 7 days after last dose of study treatment

Population: The PPS included all participants enrolled excluding those with a major protocol violation.

The AE is an undesirable or unwanted consequence that occurred during the course of the clinical trial, but not necessarily because of study drug.The AEs included the onset of new symptoms, worsening of the frequency or severity of the symptom compared with Baseline, and abnormal findings including abnormal laboratory test values in the diagnostic examination. The participants who discontinued because of lack of efficacy were those in which satisfactory analgesia was not maintained.

Outcome measures

Outcome measures
Measure	Opioid-Naive Participants Maintenance Period (Tapentadol PR) n=30 Participants Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants Maintenance Period (Tapentadol PR) n=36 Participants Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy AEs	2 participants	3 participants
Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy Lack of efficacy	0 participants	1 participants

SECONDARY outcome

Timeframe: Pre-dose (Day 1) and Day 20

Population: THe PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.

The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. The participants were asked about the time taken by them to fall asleep previous night after bedtime and the total time they slept during previous night.

Outcome measures

Outcome measures
Measure	Opioid-Naive Participants Maintenance Period (Tapentadol PR) n=29 Participants Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants Maintenance Period (Tapentadol PR) n=28 Participants Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
Sleep Questionnaire Regarding Time to Sleep and Total Time Slept Time to sleep: Pre-dose (Day 1)	47.10 minutes Standard Deviation 44.45	63.80 minutes Standard Deviation 60.70
Sleep Questionnaire Regarding Time to Sleep and Total Time Slept Time to sleep: Day 20	43.10 minutes Standard Deviation 39.47	56.60 minutes Standard Deviation 40.85
Sleep Questionnaire Regarding Time to Sleep and Total Time Slept Total time slept: Pre-dose (Day 1)	371.70 minutes Standard Deviation 119.49	390.50 minutes Standard Deviation 106.90
Sleep Questionnaire Regarding Time to Sleep and Total Time Slept Total time slept: Day 20	418.40 minutes Standard Deviation 104.21	373.00 minutes Standard Deviation 99.40

SECONDARY outcome

Timeframe: Pre-dose (Day 1) and Day 20

The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night . Participants were asked to provide the number of times they awoke at night.

Outcome measures

Outcome measures
Measure	Opioid-Naive Participants Maintenance Period (Tapentadol PR) n=29 Participants Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants Maintenance Period (Tapentadol PR) n=28 Participants Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
Sleep Questionnaire Regarding Number of Awakenings Pre-dose (Day 1)	2.40 awakenings Standard Deviation 1.70	3.40 awakenings Standard Deviation 2.28
Sleep Questionnaire Regarding Number of Awakenings Day 20	2.20 awakenings Standard Deviation 1.38	3.80 awakenings Standard Deviation 1.81

SECONDARY outcome

Timeframe: Pre-dose (Day 1) and Day 20

The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. Participants rated overall sleep quality on a scale ranging from excellent to very poor.

Outcome measures

Outcome measures
Measure	Opioid-Naive Participants Maintenance Period (Tapentadol PR) n=29 Participants Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants Maintenance Period (Tapentadol PR) n=28 Participants Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
Sleep Questionnaire Regarding the Quality of Sleep Excellent: Pre-dose (Day 1)	1 participants 3.4	0 participants 0.0
Sleep Questionnaire Regarding the Quality of Sleep Excellent: Day 20	4 participants 13.8	2 participants 7.1
Sleep Questionnaire Regarding the Quality of Sleep Good: Pre-dose (Day 1)	16 participants 55.2	20 participants 71.4
Sleep Questionnaire Regarding the Quality of Sleep Good: Day 20	17 participants 58.6	18 participants 64.3
Sleep Questionnaire Regarding the Quality of Sleep Fair: Pre-dose (Day 1)	0 participants	0 participants
Sleep Questionnaire Regarding the Quality of Sleep Fair: Day 20	8 participants	6 participants
Sleep Questionnaire Regarding the Quality of Sleep Poor: Pre-dose (Day 1)	10 participants	6 participants
Sleep Questionnaire Regarding the Quality of Sleep Poor: Day 20	0 participants	2 participants
Sleep Questionnaire Regarding the Quality of Sleep Very Poor: Pre-dose (Day 1)	2 participants	2 participants
Sleep Questionnaire Regarding the Quality of Sleep Very Poor: Day 20	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 19

PGI-C is a participant rated instrument to measure participant's change in overall status of general condition including pain on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).

Outcome measures

Outcome measures
Measure	Opioid-Naive Participants Maintenance Period (Tapentadol PR) n=29 Participants Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants Maintenance Period (Tapentadol PR) n=28 Participants Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
Patient's Global Impression of Change (PGI-C) Very much improved	1 participants 3.4	0 participants 0.0
Patient's Global Impression of Change (PGI-C) Improved	13 participants 44.8	1 participants 3.6
Patient's Global Impression of Change (PGI-C) Minimally improved	10 participants 34.5	6 participants 21.4
Patient's Global Impression of Change (PGI-C) No change	5 participants 17.2	15 participants 53.6
Patient's Global Impression of Change (PGI-C) Minimally worse	0 participants 0.0	6 participants 21.4
Patient's Global Impression of Change (PGI-C) Worse	0 participants 0.0	0 participants 0.0
Patient's Global Impression of Change (PGI-C) Very much worse	0 participants 0.0	0 participants 0.0

Adverse Events

Opioid-Naive Participants (Tapentadol PR)

Serious events: 5 serious events

Other events: 33 other events

Deaths: 0 deaths

Opioid-Switch Participants (Tapentadol PR)

Serious events: 3 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Opioid-Naive Participants (Tapentadol PR) n=36 participants at risk Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants (Tapentadol PR) n=42 participants at risk Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release \[SR\] preparation, oxycodone hydrochloride \[HCl\] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	2.8% 1/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	2.8% 1/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.00% 0/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	2.4% 1/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Blood and lymphatic system disorders Anaemia	2.8% 1/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Immune system disorders Drug hypersensitivity	0.00% 0/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	2.4% 1/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Metabolism and nutrition disorders Malnutrition	2.8% 1/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Nervous system disorders Altered state of consciousness	2.8% 1/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Cardiac disorders Bradyarrhythmia	2.8% 1/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	2.4% 1/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory depression	2.8% 1/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Gastrointestinal disorders Gastric ulcer	2.8% 1/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.

Other adverse events

Additional Information

Senior Director, Clinical Leader

Janssen R&D, 1125 Trenton-Harbourton Road, Titusville, PA 18902, USA

Phone: 609-730-6777

Results disclosure agreements

Principal investigator is a sponsor employee The disclosure restriction on PI is that the Sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the sponsor requires.
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Measure	Opioid-Naive Participants (Tapentadol PR) n=36 participants at risk Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.	Opioid-Switch Participants (Tapentadol PR) n=42 participants at risk Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release \[SR\] preparation, oxycodone hydrochloride \[HCl\] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
Investigations Blood pressure increased	5.6% 2/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	2.4% 1/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Gastrointestinal disorders Stomatitis	5.6% 2/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	2.4% 1/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	5.6% 2/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	2.4% 1/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
General disorders Pyrexia	11.1% 4/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	7.1% 3/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	11.1% 4/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	4.8% 2/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Gastrointestinal disorders Nausea	52.8% 19/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	26.2% 11/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Gastrointestinal disorders Vomiting	47.2% 17/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	14.3% 6/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Gastrointestinal disorders Constipation	41.7% 15/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	9.5% 4/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Nervous system disorders Somnolence	33.3% 12/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	11.9% 5/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Metabolism and nutrition disorders Anorexia	11.1% 4/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	7.1% 3/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Investigations White blood cell count decreased	5.6% 2/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	11.9% 5/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Nervous system disorders Dizziness	5.6% 2/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	4.8% 2/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Blood and lymphatic system disorders Anaemia	5.6% 2/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Eczema	5.6% 2/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash	5.6% 2/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Investigations White blood cell count increased	5.6% 2/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	5.6% 2/36 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.	0.00% 0/42 • Baseline up to 7 days after last dose of study treatment Safety Population consisted of participants who received at least one dose of study medication.