Cancer, Pain
Conditions
Keywords
Pain, Cancer, Tapentadol
Brief summary
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time; explores what the body does to the drug) of tapentadol prolonged release (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and spreads in the body until it kills) pain.
Detailed description
This is a Phase 2 open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), non-comparative, optional dose-titration study of tapentadol PR in Japanese participants with cancer pain. This study will consist of Screening period (3 to 7 days), Dose adjustment period (3 to 14 days), Fixed dose period (5 days) and Follow-up period (7 days). Tapentadol PR will be administered orally (taken by mouth; to be swallowed) twice daily before meal. For participants previously using opioids, the initial dose of tapentadol PR will be selected depending on the daily dose of opioid at the completion of Screening period. For opioid-naive (moderate to severe cancer pain that is not controlled adequately with non-opioid medications) participants, the initial dose of tapentadol PR will be 25 milligram (mg) twice daily. Participants will receive the same dose of tapentadol PR for the first 2 days of the dose adjustment period and from Day 3, the dose can be titrated as per the Investigator's discretion up to Day 14. After that participants will receive fixed dose regimen for 5 days at the same dose as that used at the end of the dose adjustment period. Efficacy will primarily be evaluated by sustained pain control for the 5 day fixed dose phase. Participants' safety will be monitored throughout the study.
Interventions
DRUGTapentadol PR
Tapentadol PR tablets will be administered orally twice daily initiated at dose of 25 mg. Dose will be adjusted as per Investigator's discretion. Maximum dose limit is 500 mg per day. Total duration of treatment is 19 days.
Sponsors
Grünenthal GmbH
Janssen Pharmaceutical K.K.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Opioid switching participants should meet the following criteria from a to c: a) Participants with cancer pain b) previously were on opioid medications (morphine sustained release preparations \[120 milligram per day {mg/day} or less\], oxycodone hydrochloride sustained release tablets \[80 mg/day or less\], fentanyl transdermal \[through the skin\] application system \[4.2 mg or less\]) c) had achieved adequate pain control with opioid therapy * Opioid naive participants should meet the following criteria from a to b: a) Participants with cancer pain b) should not have received any pain control therapy with opioids (excluding narcotic antagonist analgesics \[drug used to control pain\]) * Definite diagnosis of any type of cancer, which has been notified to the participant * Participants who can be hospitalized during the treatment period * Participant who can record 11 point Numerical Rating Scale (NRS) and 100 millimeter (mm) Visual Analog Scale (VAS) scores appropriately throughout the study
Exclusion criteria
* Participants with bradyarrhythmia (slow, irregular heartbeats) * History of mild or moderate traumatic (causing damage, like a toll used to crush tissue) encephalopathy, cerebral (having to do with the cerebrum) infarction (death of tissue because of lack of blood supply) or transient ischemic (decreased oxygen in a tissue \[usually because of decreased blood flow\]) attack within 1 year before informed consent * Previous or concurrent epilepsy (seizure disorder) or convulsive diseases accompanied by disturbance of consciousness * Previous or concurrent alcohol dependence or narcotic abuse * History of active hepatitis (inflammation of the liver) B or C within 3 months before informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase | Day 15 up to Day 19 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale | Baseline (Average of Day -1 and Day 0 morning scores), Day 20 | 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. |
| Pain Assessment Using Visual Analog Scale (VAS) Score | Baseline and Day 19 | 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. |
| Rescue Doses | Day 12, 13, 14, 15, 16, 17, 18 and 19 | 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. |
| Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy | Baseline up to 7 days after last dose of study treatment | 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. |
| Percentage of Participants Who Achieve Dose Adjustment | Day 3 up to Day 14 | 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. |
| Sleep Questionnaire Regarding Number of Awakenings | 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. |
| Sleep Questionnaire Regarding the Quality of Sleep | 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. |
| Patient's Global Impression of Change (PGI-C) | 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). |
| Sleep Questionnaire Regarding Time to Sleep and Total Time Slept | 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. 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. |
Countries
Japan
Participant flow
Pre-assignment details
95 participants signed the informed consent form, of which 78 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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 (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. | 30 |
| 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 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. | 36 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Maintenance Period | Adverse Event | 0 | 1 |
| Maintenance Period | Other | 0 | 1 |
| Titration Period | Adverse Event | 3 | 3 |
| Titration Period | Disease Progression | 2 | 1 |
| Titration Period | Lack of Efficacy | 1 | 1 |
| Titration Period | Lost to Follow-up | 0 | 1 |
| Titration Period | Other | 0 | 3 |
| Titration Period | Withdrawal of consent | 0 | 1 |
Baseline characteristics
| Characteristic | Opioid-Naive Participants (Tapentadol PR) | Opioid-Switch Participants (Tapentadol PR) | Total |
|---|---|---|---|
| Age Continuous | 71.7 years STANDARD_DEVIATION 9.97 | 70.0 years STANDARD_DEVIATION 8.44 | 70.7 years STANDARD_DEVIATION 9.14 |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 24 Participants |
| Sex: Female, Male Male | 20 Participants | 22 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 36 | 29 / 42 |
| serious Total, serious adverse events | 5 / 36 | 3 / 42 |
Outcome results
Primary
Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase | 89.7 percentage of participants |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase | 92.9 percentage of participants |
Secondary
Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy
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
Population: The PPS included all participants enrolled excluding those with a major protocol violation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy | AEs | 2 participants |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy | Lack of efficacy | 0 participants |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy | AEs | 3 participants |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy | Lack of efficacy | 1 participants |
Secondary
Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale
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
Population: The PPS included all participants enrolled excluding those with a major protocol violation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale | Baseline | 4.9 units on a scale | Standard Deviation 1.4 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale | Day 20 | 2.4 units on a scale | Standard Deviation 1.22 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale | Baseline | 1.3 units on a scale | Standard Deviation 1.3 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale | Day 20 | 1.7 units on a scale | Standard Deviation 1.74 |
Secondary
Pain Assessment Using Visual Analog Scale (VAS) Score
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Pain Assessment Using Visual Analog Scale (VAS) Score | Baseline | 44.34 mm | Standard Deviation 12.87 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Pain Assessment Using Visual Analog Scale (VAS) Score | Day 19 | 20.33 mm | Standard Deviation 10.874 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Pain Assessment Using Visual Analog Scale (VAS) Score | Baseline | 10.71 mm | Standard Deviation 11.623 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Pain Assessment Using Visual Analog Scale (VAS) Score | Day 19 | 10.30 mm | Standard Deviation 11.098 |
Secondary
Patient's Global Impression of Change (PGI-C)
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
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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | Very much improved | 1 participants | 3.4 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | Minimally worse | 0 participants | 0 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | Minimally improved | 10 participants | 34.5 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | Worse | 0 participants | 0 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | Improved | 13 participants | 44.8 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | Very much worse | 0 participants | 0 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | No change | 5 participants | 17.2 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | Very much worse | 0 participants | 0 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | Improved | 1 participants | 3.6 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | Minimally improved | 6 participants | 21.4 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | No change | 15 participants | 53.6 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | Minimally worse | 6 participants | 21.4 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | Worse | 0 participants | 0 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Patient's Global Impression of Change (PGI-C) | Very much improved | 0 participants | 0 |
Secondary
Percentage of Participants Who Achieve Dose Adjustment
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
Population: The PPS included all participants enrolled excluding those with a major protocol violation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Percentage of Participants Who Achieve Dose Adjustment | 93.3 percentage of participants |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Percentage of Participants Who Achieve Dose Adjustment | 80.6 percentage of participants |
Secondary
Rescue Doses
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 14 | 1.03 mg per day | Standard Deviation 2.061 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 12 | 0.34 mg per day | Standard Deviation 1.289 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 13 | 0.52 mg per day | Standard Deviation 1.55 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 15 | 1.21 mg per day | Standard Deviation 3.178 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 16 | 1.72 mg per day | Standard Deviation 3.348 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 17 | 1.72 mg per day | Standard Deviation 3.605 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 18 | 0.86 mg per day | Standard Deviation 1.922 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 19 | 1.03 mg per day | Standard Deviation 2.061 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 19 | 1.96 mg per day | Standard Deviation 4.2 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 13 | 1.16 mg per day | Standard Deviation 2.38 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 16 | 1.21 mg per day | Standard Deviation 2.795 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 12 | 1.07 mg per day | Standard Deviation 2.562 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 18 | 2.32 mg per day | Standard Deviation 5.639 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 14 | 1.61 mg per day | Standard Deviation 3.4 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 17 | 1.56 mg per day | Standard Deviation 3.513 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Rescue Doses | Day 15 | 2.05 mg per day | Standard Deviation 4.503 |
Secondary
Sleep Questionnaire Regarding Number of Awakenings
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding Number of Awakenings | Pre-dose (Day 1) | 2.40 awakenings | Standard Deviation 1.7 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding Number of Awakenings | Day 20 | 2.20 awakenings | Standard Deviation 1.38 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding Number of Awakenings | Pre-dose (Day 1) | 3.40 awakenings | Standard Deviation 2.28 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding Number of Awakenings | Day 20 | 3.80 awakenings | Standard Deviation 1.81 |
Secondary
Sleep Questionnaire Regarding the Quality of Sleep
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
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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Excellent: Pre-dose (Day 1) | 1 participants | 3.4 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Fair: Day 20 | 8 participants | — |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Good: Pre-dose (Day 1) | 16 participants | 55.2 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Poor: Pre-dose (Day 1) | 10 participants | — |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Good: Day 20 | 17 participants | 58.6 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Poor: Day 20 | 0 participants | — |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Very Poor: Pre-dose (Day 1) | 2 participants | — |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Excellent: Day 20 | 4 participants | 13.8 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Very Poor: Day 20 | 0 participants | — |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Fair: Pre-dose (Day 1) | 0 participants | — |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Very Poor: Day 20 | 0 participants | — |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Excellent: Pre-dose (Day 1) | 0 participants | 0 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Excellent: Day 20 | 2 participants | 7.1 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Good: Pre-dose (Day 1) | 20 participants | 71.4 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Good: Day 20 | 18 participants | 64.3 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Fair: Pre-dose (Day 1) | 0 participants | — |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Fair: Day 20 | 6 participants | — |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Poor: Pre-dose (Day 1) | 6 participants | — |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Very Poor: Pre-dose (Day 1) | 2 participants | — |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding the Quality of Sleep | Poor: Day 20 | 2 participants | — |
Secondary
Sleep Questionnaire Regarding Time to Sleep and Total Time Slept
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding Time to Sleep and Total Time Slept | Time to sleep: Pre-dose (Day 1) | 47.10 minutes | Standard Deviation 44.45 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding Time to Sleep and Total Time Slept | Time to sleep: Day 20 | 43.10 minutes | Standard Deviation 39.47 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding Time to Sleep and Total Time Slept | Total time slept: Pre-dose (Day 1) | 371.70 minutes | Standard Deviation 119.49 |
| Opioid-Naive Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding Time to Sleep and Total Time Slept | Total time slept: Day 20 | 418.40 minutes | Standard Deviation 104.21 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding Time to Sleep and Total Time Slept | Total time slept: Day 20 | 373.00 minutes | Standard Deviation 99.4 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding Time to Sleep and Total Time Slept | Time to sleep: Pre-dose (Day 1) | 63.80 minutes | Standard Deviation 60.7 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding Time to Sleep and Total Time Slept | Total time slept: Pre-dose (Day 1) | 390.50 minutes | Standard Deviation 106.9 |
| Opioid-Switch Participants Maintenance Period (Tapentadol PR) | Sleep Questionnaire Regarding Time to Sleep and Total Time Slept | Time to sleep: Day 20 | 56.60 minutes | Standard Deviation 40.85 |