Neoplasms
Conditions
Keywords
Tapentadol, Tumor related pain, Opioid, Cancer related pain, Morphine
Brief summary
The purpose of this study is to evaluate the conversion rate based on the number of participants achieving pain control and safety within 1 week after switching the opioid (morphine-like medications) analgesics (drug used to control pain), when tapentadol extended-release (ER) (JNS024ER) is orally administered to participants treated with around-the-clock opioid analgesics, for their moderate to severe (very serious, life threatening) chronic (lasting a long time) malignant (cancerous) tumor-related (a mass in a specific area) cancer (abnormal tissue that grows and spreads in the body) pain.
Detailed description
This is a randomized (study drug assigned by chance), open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, unblinded), parallel-arm (participants receive 1 of 2 possible interventions during the same time frame throughout the study), optimal dose-titration, multicenter (when more than one hospital or medical school team work on a medical research study) study evaluating the conversion rate based on the number of participants achieving pain control and safety within 1 week after switching from an ongoing around-the-clock opioid analgesic (morphine sustained-release \[SR\], oxycodone controlled-release, or fentanyl transdermal) to tapentadol ER or morphine SR, for their moderate to severe chronic, malignant tumor-related cancer pain. The study consists of 2 periods: 1 to 2 week screening period, followed by 8-week open-label treatment period. During the study period, participants will be hospitalized or outpatient. However, it is preferable to be hospitalized 1 week before and 1 week after to evaluate efficacy before and after switching opioids for securing participants' safety. At Day 1, participants will receive either tapentadol ER or morphine SR twice daily. During the treatment period, the dose of the study drug will be titrated to the participant's optimal dose. The participants will receive either tapentadol ER or morphine SR twice daily for 8 weeks. The maximum dose allowed for tapentadol ER will be 500 milligram (mg) daily or morphine SR 140 mg daily throughout the study. Efficacy is primarily evaluated using pain intensity score on an 11 point Numerical Rating Scale (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine). Participants' safety will also be monitored.
Interventions
DRUGTapentadol ER
Tapentadol ER 100 to 400 milligram (mg) orally daily for 8 weeks (maximum up to 500 mg daily), as per Investigator's discretion.
DRUGMorphine SR
Morphine SR 30 to 120 mg orally daily for 8 weeks (maximum up to 140 mg daily), as per Investigator's discretion.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with documented clinical diagnosis (determination of the cause of a medical problem) of any type of cancer (abnormal tissue that grows and spreads in the body) * Participants with mean 24-hour Numerical Rating Scale (NRS) score (11-point NRS used to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine) during 3 days (Day -4 to Day -2) before randomization (study drug assigned by chance) less than 4.0 * Women must be post-menopausal, surgically sterile, or before entry and throughout the study practicing an effective method of birth control * Participants using immediate-release (IR) morphine hydrochloride (HCl) or oxycodone HCl hydrate as rescue medication (rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) for breakthrough pain * Participants treated with around-the-clock opioid (morphine-like medications) therapy for moderate to severe (very serious, life threatening) chronic (lasting a long time), malignant (cancerous) tumor-related (a mass in a specific area) cancer (abnormal tissue that grows and spreads in the body) pain using one of the following opioid analgesics (drug used to control pain) before randomization: morphine SR tablet less than or equal to 120 milligram (mg) per day, oxycodone hydrochloride controlled release (CR) tablet: 15 mg to 80 mg per day, durotep MT (fentanyl transdermal \[through the skin\] matrix) patch less than or equal to 8.4 mg per patch, fentos tape less than or equal to 4 mg per tape, or oneduro patch less than or equal to 3.4 mg per patch
Exclusion criteria
* Participants with complicated uncontrolled/clinically significant arrhythmia (uneven heart beat) * Participants who had received rescue doses 3 times or more daily within 3 days (Day -4 to Day -2) before the randomization * History of surgery intended for the cure of the primary disease or for the treatment of cancer pain within 28 days before screening * Participants who had application of radiotherapy (treatment of cancer using x-rays), nerve block, or stimulation analgesia within 7 days before screening * Participants with known allergies (over sensitivity to a substance), hypersensitivity, or intolerance to opioid analgesics or its excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Pain Control | Week 1 | Pain control was considered to be achieved for participants who met both of the following criteria for any consecutive 3 days during the first week of treatment period: a) Change from baseline of mean 24 hour numerical rating scale (NRS) (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine) score less than +1.5, and b) when the frequency of rescue medication was twice or less per day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy | Baseline up to Week 8 | Number of participants who discontinued the treatment due to lack of efficacy were assessed throughout the study. |
| Number of Participants With Patient Global Impression of Change (PGIC) | Week 1, 4 and 8 | The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. |
| Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Average pain intensity was assessed using an 11-point NRS to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine. |
| Number of Doses of Rescue Medication Over Time | Baseline up to Week 8 | Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. |
| Average Change From Baseline in Amount of Rescue Medication Over Time | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. Average amount was the averages of all doses recorded during the baseline period or during each week (Week 1, 2, 3, 4, 5, 6, 7 and 8). |
| Total Number of Days of Rescue Medication Over Time | Baseline up to Week 8 | Total number of days of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tapentadol ER Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion. | 50 |
| Morphine SR Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 8 |
| Overall Study | Lack of Efficacy | 3 | 1 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Progressive disease | 9 | 11 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Tapentadol ER | Morphine SR | Total |
|---|---|---|---|
| Age, Customized Less than 65 years | 23 Participants 8.5 | 25 Participants 9.97 | 48 Participants |
| Age, Customized More than or equal to 65 years | 27 Participants | 25 Participants | 52 Participants |
| Sex: Female, Male Female | 25 Participants | 23 Participants | 48 Participants |
| Sex: Female, Male Male | 25 Participants | 27 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 43 / 50 | 44 / 50 |
| serious Total, serious adverse events | 16 / 50 | 16 / 50 |
Outcome results
Primary
Percentage of Participants Who Achieved Pain Control
Pain control was considered to be achieved for participants who met both of the following criteria for any consecutive 3 days during the first week of treatment period: a) Change from baseline of mean 24 hour numerical rating scale (NRS) (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine) score less than +1.5, and b) when the frequency of rescue medication was twice or less per day.
Time frame: Week 1
Population: Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tapentadol ER | Percentage of Participants Who Achieved Pain Control | 84.0 Percentage of Participants |
| Morphine SR | Percentage of Participants Who Achieved Pain Control | 98.0 Percentage of Participants |
Secondary
Average Change From Baseline in Amount of Rescue Medication Over Time
Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. Average amount was the averages of all doses recorded during the baseline period or during each week (Week 1, 2, 3, 4, 5, 6, 7 and 8).
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Population: Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tapentadol ER | Average Change From Baseline in Amount of Rescue Medication Over Time | 3.02 Milligram (mg) | Standard Deviation 8.303 |
| Morphine SR | Average Change From Baseline in Amount of Rescue Medication Over Time | -0.15 Milligram (mg) | Standard Deviation 5.038 |
Secondary
Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8
Average pain intensity was assessed using an 11-point NRS to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Population: Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data. Here 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol ER | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 1 (n = 50, 50) | 0.4 Unit on scale | Standard Deviation 0.92 |
| Tapentadol ER | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 2 (n = 45, 44) | 0.3 Unit on scale | Standard Deviation 1.11 |
| Tapentadol ER | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 3 (n= 41, 41) | 0.1 Unit on scale | Standard Deviation 0.9 |
| Tapentadol ER | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 4 (n = 38, 37) | 0.1 Unit on scale | Standard Deviation 0.9 |
| Tapentadol ER | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 5 (n = 36, 34) | 0.1 Unit on scale | Standard Deviation 0.92 |
| Tapentadol ER | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 6 (n = 36, 32) | 0.2 Unit on scale | Standard Deviation 0.97 |
| Tapentadol ER | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 7 (n = 34, 29) | 0.1 Unit on scale | Standard Deviation 1 |
| Tapentadol ER | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 8 (n = 29, 29) | 0.0 Unit on scale | Standard Deviation 0.92 |
| Morphine SR | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 8 (n = 29, 29) | 0.0 Unit on scale | Standard Deviation 1.21 |
| Morphine SR | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 1 (n = 50, 50) | -0.2 Unit on scale | Standard Deviation 0.84 |
| Morphine SR | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 5 (n = 36, 34) | -0.1 Unit on scale | Standard Deviation 1.22 |
| Morphine SR | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 2 (n = 45, 44) | -0.3 Unit on scale | Standard Deviation 0.75 |
| Morphine SR | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 7 (n = 34, 29) | 0.1 Unit on scale | Standard Deviation 1.05 |
| Morphine SR | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 3 (n= 41, 41) | -0.1 Unit on scale | Standard Deviation 1.03 |
| Morphine SR | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 6 (n = 36, 32) | 0.1 Unit on scale | Standard Deviation 1.43 |
| Morphine SR | Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8 | Change at Week 4 (n = 38, 37) | -0.3 Unit on scale | Standard Deviation 0.95 |
Secondary
Number of Doses of Rescue Medication Over Time
Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.
Time frame: Baseline up to Week 8
Population: Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tapentadol ER | Number of Doses of Rescue Medication Over Time | 0.7 Morphine-equivalent doses | Standard Deviation 0.89 |
| Morphine SR | Number of Doses of Rescue Medication Over Time | 0.4 Morphine-equivalent doses | Standard Deviation 0.53 |
Secondary
Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy
Number of participants who discontinued the treatment due to lack of efficacy were assessed throughout the study.
Time frame: Baseline up to Week 8
Population: Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tapentadol ER | Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy | 3 Participants |
| Morphine SR | Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy | 1 Participants |
Secondary
Number of Participants With Patient Global Impression of Change (PGIC)
The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved.
Time frame: Week 1, 4 and 8
Population: Full analysis set (FAS) population; here 'N' signifies those participants evaluable for this outcome measure and 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (minimally improved) (n=48,48) | 11 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (much improved) (n=37,37) | 2 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (minimally improved) (n=28,28) | 8 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (minimally improved) (n=37,37) | 9 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (not changed) (n=48,48) | 24 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (not changed) (n=37,37) | 22 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (very much improved) (n=48,48) | 1 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (minimally worse) (n=37,37) | 3 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (minimally worse) (n=48,48) | 9 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (much worse) (n=37,37) | 0 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (not changed) (n=28,28) | 15 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (very much worse) (n=37,37) | 0 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (much improved) (n=48,48) | 1 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (very much improved) (n=28,28) | 0 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (very much worse) (n=48,48) | 0 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (much improved) (n=28,28) | 3 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (minimally worse) (n=28,28) | 2 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (much worse) (n=28,28) | 0 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (very much improved) (n=37,37) | 1 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (very much worse) (n=28,28) | 0 Participants |
| Tapentadol ER | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (much worse) (n=48,48) | 2 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (very much worse) (n=28,28) | 0 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (much improved) (n=28,28) | 2 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (minimally improved) (n=28,28) | 4 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (minimally worse) (n=28,28) | 4 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (very much improved) (n=48,48) | 2 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (much improved) (n=48,48) | 4 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (minimally improved) (n=48,48) | 7 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (not changed) (n=48,48) | 29 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (minimally worse) (n=48,48) | 6 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (much worse) (n=48,48) | 0 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 1 (very much worse) (n=48,48) | 0 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (very much improved) (n=37,37) | 3 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (much improved) (n=37,37) | 5 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (minimally improved) (n=37,37) | 7 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (not changed) (n=37,37) | 19 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (minimally worse) (n=37,37) | 3 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (much worse) (n=37,37) | 0 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 4 (very much worse) (n=37,37) | 0 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (very much improved) (n=28,28) | 3 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (not changed) (n=28,28) | 13 Participants |
| Morphine SR | Number of Participants With Patient Global Impression of Change (PGIC) | Week 8 (much worse) (n=28,28) | 2 Participants |
Secondary
Total Number of Days of Rescue Medication Over Time
Total number of days of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.
Time frame: Baseline up to Week 8
Population: Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tapentadol ER | Total Number of Days of Rescue Medication Over Time | 15.9 Days | Standard Deviation 19.58 |
| Morphine SR | Total Number of Days of Rescue Medication Over Time | 9.2 Days | Standard Deviation 12.76 |