Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 2 Study of Tapentadol Prolonged Release in Cancer Pain Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00805142
Recruitment Status : Completed
First Posted : December 9, 2008
Results First Posted : July 29, 2013
Last Update Posted : July 29, 2013
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pain
Cancer
Intervention Drug: Tapentadol PR
Enrollment 78
Recruitment Details  
Pre-assignment Details 95 participants signed the informed consent form, of which 78 participants were enrolled in the study.
Arm/Group Title Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants (Tapentadol PR)
Hide Arm/Group Description 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-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.
Period Title: Titration Period
Started 36 42
Completed 30 32
Not Completed 6 10
Reason Not Completed
Adverse Event             3             3
Lack of Efficacy             1             1
Lost to Follow-up             0             1
Disease Progression             2             1
Withdrawal of consent             0             1
Other             0             3
Period Title: Maintenance Period
Started 30 32
Completed 30 30
Not Completed 0 2
Reason Not Completed
Adverse Event             0             1
Other             0             1
Arm/Group Title Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants (Tapentadol PR) Total
Hide Arm/Group Description 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-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 of all reporting groups
Overall Number of Baseline Participants 30 36 66
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 36 participants 66 participants
71.7  (9.97) 70.0  (8.44) 70.7  (9.14)
[1]
Measure Description: Out of a total of 78 participants, Baseline characteristic (Age) was available for only 66 participants who were included in per protocol (PP) population.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 36 participants 66 participants
Female
10
  33.3%
14
  38.9%
24
  36.4%
Male
20
  66.7%
22
  61.1%
42
  63.6%
[1]
Measure Description: Out of a total of 78 participants, Baseline characteristic (Gender) was available for only 66 participants who were included in PP population
1.Primary Outcome
Title Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase
Hide Description 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.
Time Frame Day 15 up to Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Opioid-Naive Participants Maintenance Period (Tapentadol PR) Opioid-Switch Participants Maintenance Period (Tapentadol PR)
Hide Arm/Group Description:
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-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.
Overall Number of Participants Analyzed 29 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89.7
(72.6 to 97.8)
92.9
(76.5 to 99.1)
2.Secondary Outcome
Title Percentage of Participants Who Achieve Dose Adjustment
Hide Description 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.
Time Frame Day 3 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The PPS included all participants enrolled excluding those with a major protocol violation.
Arm/Group Title Opioid-Naive Participants Titration Period (Tapentadol PR) Opioid-Switch Participants Titration Period (Tapentadol PR)
Hide Arm/Group Description:
Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Treatment was initiated with tapentadol PR 25 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.
Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Initial dose of tapentadol PR was selected according to the daily dose of opioid (morphine sustained release (SR) preparation, oxycodone hydrochloride (HCl) SR tablet or fentanyl patch). Equivalent dose of the 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.
Overall Number of Participants Analyzed 30 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.3
(77.9 to 99.2)
80.6
(64.0 to 91.8)
3.Secondary Outcome
Title Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale
Hide Description 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.
Time Frame Baseline (Average of Day -1 and Day 0 morning scores), Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
The PPS included all participants enrolled excluding those with a major protocol violation.
Arm/Group Title Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants (Tapentadol PR)
Hide Arm/Group Description:
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-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.
Overall Number of Participants Analyzed 30 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 4.9  (1.40) 1.3  (1.30)
Day 20 2.4  (1.22) 1.7  (1.74)
4.Secondary Outcome
Title Pain Assessment Using Visual Analog Scale (VAS) Score
Hide Description 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.
Time Frame Baseline and Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
The PPS included all participants enrolled excluding those with a major protocol violation. Missing values were imputed using last observed carried forward (LOCF) method.
Arm/Group Title Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants (Tapentadol PR)
Hide Arm/Group Description:
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-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.
Overall Number of Participants Analyzed 30 36
Mean (Standard Deviation)
Unit of Measure: mm
Baseline 44.34  (12.870) 10.71  (11.623)
Day 19 20.33  (10.874) 10.30  (11.098)
5.Secondary Outcome
Title Rescue Doses
Hide Description 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.
Time Frame Day 12, 13, 14, 15, 16, 17, 18 and 19
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants (Tapentadol PR)
Hide Arm/Group Description:
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-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.
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: mg per day
Day 12 0.34  (1.289) 1.07  (2.562)
Day 13 0.52  (1.550) 1.16  (2.380)
Day 14 1.03  (2.061) 1.61  (3.400)
Day 15 1.21  (3.178) 2.05  (4.503)
Day 16 1.72  (3.348) 1.21  (2.795)
Day 17 1.72  (3.605) 1.56  (3.513)
Day 18 0.86  (1.922) 2.32  (5.639)
Day 19 1.03  (2.061) 1.96  (4.200)
6.Secondary Outcome
Title Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy
Hide Description 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.
Time Frame Baseline up to 7 days after last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The PPS included all participants enrolled excluding those with a major protocol violation.
Arm/Group Title Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants (Tapentadol PR)
Hide Arm/Group Description:
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-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.
Overall Number of Participants Analyzed 30 36
Measure Type: Number
Unit of Measure: participants
AEs 2 3
Lack of efficacy 0 1
7.Secondary Outcome
Title Sleep Questionnaire Regarding Time to Sleep and Total Time Slept
Hide Description 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.
Time Frame Pre-dose (Day 1) and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants Maintenance Period (Tapentadol PR)
Hide Arm/Group Description:
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-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.
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: minutes
Time to sleep: Pre-dose (Day 1) 47.10  (44.45) 63.80  (60.70)
Time to sleep: Day 20 43.10  (39.47) 56.60  (40.85)
Total time slept: Pre-dose (Day 1) 371.70  (119.49) 390.50  (106.90)
Total time slept: Day 20 418.40  (104.21) 373.00  (99.40)
8.Secondary Outcome
Title Sleep Questionnaire Regarding Number of Awakenings
Hide Description 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.
Time Frame Pre-dose (Day 1) and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants (Tapentadol PR)
Hide Arm/Group Description:
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-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.
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: awakenings
Pre-dose (Day 1) 2.40  (1.70) 3.40  (2.28)
Day 20 2.20  (1.38) 3.80  (1.81)
9.Secondary Outcome
Title Sleep Questionnaire Regarding the Quality of Sleep
Hide Description 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.
Time Frame Pre-dose (Day 1) and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants (Tapentadol PR)
Hide Arm/Group Description:
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-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.
Overall Number of Participants Analyzed 29 28
Measure Type: Number
Unit of Measure: participants
Excellent: Pre-dose (Day 1) 1 0
Excellent: Day 20 4 2
Good: Pre-dose (Day 1) 16 20
Good: Day 20 17 18
Fair: Pre-dose (Day 1) 0 0
Fair: Day 20 8 6
Poor: Pre-dose (Day 1) 10 6
Poor: Day 20 0 2
Very Poor: Pre-dose (Day 1) 2 2
Very Poor: Day 20 0 0
10.Secondary Outcome
Title Patient's Global Impression of Change (PGI-C)
Hide Description 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).
Time Frame Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Opioid-Naive Participants Maintenance Period (Tapentadol PR) Opioid-Switch Participants Maintenance Period (Tapentadol PR)
Hide Arm/Group Description:
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 PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
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 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.
Overall Number of Participants Analyzed 29 28
Measure Type: Number
Unit of Measure: participants
Very much improved 1 0
Improved 13 1
Minimally improved 10 6
No change 5 15
Minimally worse 0 6
Worse 0 0
Very much worse 0 0
Time Frame Baseline up to 7 days after last dose of study treatment
Adverse Event Reporting Description Safety Population consisted of participants who received at least one dose of study medication.
 
Arm/Group Title Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants (Tapentadol PR)
Hide Arm/Group Description 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-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.
All-Cause Mortality
Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants (Tapentadol PR)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants (Tapentadol PR)
Affected / at Risk (%) Affected / at Risk (%)
Total   5/36 (13.89%)   3/42 (7.14%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/36 (2.78%)  0/42 (0.00%) 
Cardiac disorders     
Bradyarrhythmia * 1  1/36 (2.78%)  0/42 (0.00%) 
Gastrointestinal disorders     
Gastric ulcer * 1  1/36 (2.78%)  0/42 (0.00%) 
Immune system disorders     
Drug hypersensitivity * 1  0/36 (0.00%)  1/42 (2.38%) 
Metabolism and nutrition disorders     
Malnutrition * 1  1/36 (2.78%)  0/42 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pancreatic carcinoma * 1  1/36 (2.78%)  0/42 (0.00%) 
Lung neoplasm malignant * 1  1/36 (2.78%)  0/42 (0.00%) 
Gastric neoplasm * 1  0/36 (0.00%)  1/42 (2.38%) 
Nervous system disorders     
Altered state of consciousness * 1  1/36 (2.78%)  0/42 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory arrest * 1  0/36 (0.00%)  1/42 (2.38%) 
Respiratory depression * 1  1/36 (2.78%)  0/42 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Opioid-Naive Participants (Tapentadol PR) Opioid-Switch Participants (Tapentadol PR)
Affected / at Risk (%) Affected / at Risk (%)
Total   33/36 (91.67%)   29/42 (69.05%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/36 (5.56%)  0/42 (0.00%) 
Gastrointestinal disorders     
Stomatitis * 1  2/36 (5.56%)  1/42 (2.38%) 
Diarrhoea * 1  4/36 (11.11%)  2/42 (4.76%) 
Nausea * 1  19/36 (52.78%)  11/42 (26.19%) 
Vomiting * 1  17/36 (47.22%)  6/42 (14.29%) 
Constipation * 1  15/36 (41.67%)  4/42 (9.52%) 
General disorders     
Pyrexia * 1  4/36 (11.11%)  3/42 (7.14%) 
Investigations     
Blood pressure increased * 1  2/36 (5.56%)  1/42 (2.38%) 
White blood cell count decreased * 1  2/36 (5.56%)  5/42 (11.90%) 
White blood cell count increased * 1  2/36 (5.56%)  0/42 (0.00%) 
Metabolism and nutrition disorders     
Anorexia * 1  4/36 (11.11%)  3/42 (7.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant * 1  2/36 (5.56%)  0/42 (0.00%) 
Nervous system disorders     
Somnolence * 1  12/36 (33.33%)  5/42 (11.90%) 
Dizziness * 1  2/36 (5.56%)  2/42 (4.76%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  2/36 (5.56%)  1/42 (2.38%) 
Eczema * 1  2/36 (5.56%)  0/42 (0.00%) 
Rash * 1  2/36 (5.56%)  0/42 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director, Clinical Leader
Organization: Janssen R&D, 1125 Trenton-Harbourton Road, Titusville, PA 18902, USA
Phone: 609-730-6777
Layout table for additonal information
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00805142    
Other Study ID Numbers: CR015532
JNS024PR-JPN-C01
First Submitted: December 8, 2008
First Posted: December 9, 2008
Results First Submitted: March 22, 2013
Results First Posted: July 29, 2013
Last Update Posted: July 29, 2013