Chronic Pain, Low Back Pain
Conditions
Keywords
low back pain, pain, assessment, tapentadol, centrally acting analgesic
Brief summary
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome. The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.
Interventions
DRUGTapentadol PR
Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg Tapentadol PR twice daily, adjusted with 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed a dose of 500 mg of Tapentadol per day.
OTHERObservation period
Eligibility assessment period to characterize the baseline over a one week period (week -1). Participants continued their previous treatment prior to allocation to tapentadol, if eligible.
Sponsors
Grünenthal GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have signed an Informed Consent Form. * Participants were men or non-pregnant, non-lactating women. Female participants must be postmenopausal, surgically sterile, or practicing an effective method of birth control. Women of childbearing potential must have a negative pregnancy test at screening. * Participants must be appropriately communicative to verbalize and to differentiate with regard to location and intensity of the pain. * Participants must be at least 18 years of age. * Participants must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months. * If the participant has radicular pain, this must have been present for at least 3 months and stable for the 4 weeks before enrollment. * Participants's pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator. * Participants must report a rate of satisfaction with their previous analgesic regimen not exceeding fair on a subject satisfaction with treatment scale (5-point VRS). * If under regular, daily pretreatment: * Participants must be taking a WHO Step I or Step II analgesic medication on a daily basis for at least 2 weeks prior to the Screening Visit. * The Investigator considers dose increase of WHO Step I analgesics (as mono- or combination therapy) and/or continuation with or dose increase of WHO Step II analgesics inadequate for the individual participant, whatever applicable. * Participants must have an average pain intensity score (NRS 3) greater than 5 points during the last 3 days prior to the Screening Visit. or * If no regular analgesic pretreatment is reported: * Participants must have an average pain intensity score (NRS-3) greater than 6 points in the last 3 days prior to the Screening Visit and related to low back pain.
Exclusion criteria
* Presence of a clinically significant disease or laboratory findings that in the Investigator's opinion may affect efficacy or safety assessments. * Presence of active systemic or local infection that may, in the opinion of the Investigator, affect the efficacy, quality of life/function or safety assessments. * History of alcohol or drug abuse, or suspicion of in Investigator's judgement. * Presence of concomitant autoimmune inflammatory conditions. * Known history of or laboratory values reflecting severe renal impairment. * Known history of moderately or severely impaired hepatic function. * History of or active hepatitis B or C within the past 3 months or history of HIV infection * History of seizure disorder or epilepsy. * Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post-traumatic amnesia lasting more than 24 h) or residual sequelae suggesting transient changes in consciousness. * Pregnant or breast-feeding. * History of allergy to, or hypersensitivity to tapentadol hydrochloride or its excipients, or contraindications related to tapentadol hydrochloride including: * Participants with acute or severe bronchial asthma or hypercapnia. * Participants who have or are suspected of having paralytic ileus. * Employees of the Investigator or trial site, with direct involvement in this trial or other trials under the direction of the Investigator or trial site, as well as family members of employees of the Investigator. * Participation in another trial concurrently or within 4 weeks prior to the Screening Visit. * Known to or suspected of not being able to comply with the protocol and the use of the investigational medicinal product. * Use of monoamine oxidase inhibitors within 14 days before the Screening Visit. * Non-stable dosing of selective serotonin reuptake inhibitors within 30 days before the Screening Visit (the doses must remain stable during the trial). * Presence of conditions other than low back pain that could confound the assessment or self evaluation of pain, e.g., anatomical deformities, significant skin conditions such as abscess or syndromes with widespread pain such as fibromyalgia. * Any concomitant painful condition that could interfere with the subject's trial assessments or with their ability to differentiate low back pain from other painful conditions. * Any painful procedures during the trial (e.g., major surgery) that may, in the opinion of the Investigator, affect the efficacy or safety assessments. * Pending litigation due to chronic pain or disability. * Intake of Step III analgesics within the 30 days prior to the Screening Visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline). | Baseline; End of Week 6 (6 Weeks) | For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change at End of the Maintenance Period | Baseline; End of Week 12 (12 weeks) | In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse. |
| Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period | Baseline; End of Week 6 (6 weeks) | The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline. |
| Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period | Baseline; End of Week 12 (12 weeks) | The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline. |
| painDETECT Assessment at Baseline | Baseline | The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear. |
| painDETECT Assessment for Participants at End of Titration and Optimal Dose Period | End of Week 6 | The baseline painDETECT score was reassessed at the end of Week 6. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear. |
| painDETECT Assessment for Participants at End of the Maintenance Period | End of Week 12 | The baseline painDETECT score was reassessed at the end of Week 12. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear. |
| Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline | Baseline Visit | Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales. |
| Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period | End of Week 6 | Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales. |
| Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period | End of Week 12 | Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales. |
| Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of Titration and Optimal Dose Period | Baseline; End of Week 6 (6 Weeks) | Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms. |
| Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of the Maintenance Period | Baseline; End of Week 12 (12 Weeks) | Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms. |
| EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period. | Baseline; End of Week 6 (6 weeks) | The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved. |
| Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period. | Baseline; End of Week 6 (6 weeks) | EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement. |
| EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period | Baseline; End of Week 12 (12 weeks) | The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved. |
| Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period | Baseline; End of Week 12 (12 weeks) | EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement. |
| Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period | Baseline; End of Week 6 (6 weeks) | In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse. |
| Clinical Global Impression of Change (All Participants) at End of Maintenance Period | Baseline; End of Week 12 (12 weeks) | In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse. |
| Patient Global Impression of Change at End of Titration and Optimal Dose Period | Baseline; End of Week 6 (6 Weeks) | In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse. |
| Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period | Baseline; End of Week 6 (6 weeks) | Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A negative value indicates that there has been an improvement. |
| Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period | Baseline; End of Week 12 (12 Weeks) | Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A negative value indicates that there has been an improvement. |
| Hospital Anxiety Depression Scale: Depression Score at Baseline | Baseline | Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A negative value indicates that there has been an improvement. |
| Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period. | Baseline; End of Week 6 (6 weeks) | Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A negative value indicates that there has been an improvement. |
| Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period | Baseline; End of Week 12 (12 Weeks) | Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A negative value indicates that there has been an improvement. |
| Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period. | Week 6 | Tapentadol hydrochloride PR dose after 5 weeks of titration which was to be kept stable during the remained of the trial. |
| Participant's Satisfaction With Previous Analgesic Treatment at Baseline | Baseline | Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous analgesic medication was rated as excellent, very good, good, fair and poor. |
| Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period. | End of Week 6 | Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor. |
| Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period. | End of Week 8 | Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor. |
| Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period. | End of Week 12 | Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor. |
| Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline. | Baseline | For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. |
| NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period. | End of Week 6 | For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. |
| NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period. | End of Week 12 | For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. |
| Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline. | Baseline | For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. |
| NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period. | End of Week 6 | For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. |
| NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period. | End of Week 12 | For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. |
| Hospital Anxiety Depression Scale (HADS): Anxiety Score at Baseline | Baseline | Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A negative value indicates that there has been an improvement. |
Countries
Austria, Croatia, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom
Participant flow
Recruitment details
The trial started on 30 September 2009 with enrollment of the first subject and the last follow-up examination took place on 06 July 2010.
Pre-assignment details
During the observation period (3 to 7 days in length) subjects recorded their analgesic medication intake and pain intensity. Prior to intake of tapentadol.
Participants by arm
| Arm | Count |
|---|---|
| Tapentadol All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. | 176 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Observation Period | Not eligible to be dosed | 20 |
| Observation Period | Not Evaluable due to Non Compliance | 12 |
Baseline characteristics
| Characteristic | Tapentadol |
|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 11.8 |
| Prior analgesic medication Participants opioid naive (Step 1 analgesics) | 87 participants |
| Prior analgesic medication Participants pretreated with opioids | 88 participants |
| Prior analgesic medication Unknown | 1 participants |
| Region of Enrollment Austria | 26 participants |
| Region of Enrollment France | 14 participants |
| Region of Enrollment Germany | 46 participants |
| Region of Enrollment Italy | 12 participants |
| Region of Enrollment Poland | 11 participants |
| Region of Enrollment Spain | 52 participants |
| Region of Enrollment Switzerland | 3 participants |
| Region of Enrollment United Kingdom | 12 participants |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 148 / 176 |
| serious Total, serious adverse events | 7 / 176 |
Outcome results
Primary
The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline).
For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity.
Time frame: Baseline; End of Week 6 (6 Weeks)
Population: Intention to treat. Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tapentadol | The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline). | -2.8 Units on a scale | Standard Deviation 2.12 |
Secondary
Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline.
For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.
Time frame: Baseline
Population: Intention to treat (ITT). Negative painDETECT subpopulation - 31 participants. Unclear and positive painDETECT subpopulation - 56 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline. | Negative painDETECT participants | 7.3 Units on a scale | Standard Deviation 0.78 |
| Tapentadol | Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline. | Unclear and positive painDETECT participants | 7.4 Units on a scale | Standard Deviation 1 |
Secondary
Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline.
For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.
Time frame: Baseline
Population: Intention to treat (ITT). Negative painDETECT subpopulation - 18 participants. Unclear and positive painDETECT subpopulation - 70 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline. | Unclear and positive painDETECT participants | 7.6 Units on a scale | Standard Deviation 1.07 |
| Tapentadol | Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline. | Negative painDETECT participants | 6.7 Units on a scale | Standard Deviation 0.96 |
Secondary
Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period
EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.
Time frame: Baseline; End of Week 12 (12 weeks)
Population: Intention to treat (ITT). painDETECT negative subpopulation - 23 participants. Unclear and positive painDETECT subpopulation - 66 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period | All participants | 20.0 Units on a scale | Standard Deviation 27.27 |
| Tapentadol | Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period | Participants painDETECT negative | 14.7 Units on a scale | Standard Deviation 26.68 |
| Tapentadol | Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period | Participant painDETECT unclear or positive | 21.8 Units on a scale | Standard Deviation 27.44 |
Secondary
Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period.
EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.
Time frame: Baseline; End of Week 6 (6 weeks)
Population: Intention to treat (ITT). painDETECT negative subpopulation - 34 participants. Unclear and positive painDETECT subpopulation - 97 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period. | All participants | 12.2 Units on a scale | Standard Deviation 25.08 |
| Tapentadol | Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period. | Participants painDETECT negative | 7.6 Units on a scale | Standard Deviation 19.74 |
| Tapentadol | Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period. | Participant painDETECT unclear or positive | 13.8 Units on a scale | Standard Deviation 26.61 |
Secondary
Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of the Maintenance Period
Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.
Time frame: Baseline; End of Week 12 (12 Weeks)
Population: Intention to treat (ITT), Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tapentadol | Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of the Maintenance Period | -0.296 units on a scale | Standard Deviation 0.228 |
Secondary
Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of Titration and Optimal Dose Period
Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.
Time frame: Baseline; End of Week 6 (6 Weeks)
Population: Intention to treat (ITT), Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tapentadol | Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of Titration and Optimal Dose Period | -0.224 Units on a scale | Standard Deviation 0.213 |
Secondary
Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period
The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.
Time frame: Baseline; End of Week 12 (12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period | Physical Functioning | 15.7 Units on a scale | Standard Deviation 21.95 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period | Bodily Pain | 24.4 Units on a scale | Standard Deviation 21.96 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period | General Health | 10.3 Units on a scale | Standard Deviation 14.95 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period | Vitality | 9.5 Units on a scale | Standard Deviation 18.43 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period | Social Functioning | 13.2 Units on a scale | Standard Deviation 27.85 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period | Role Emotional | 18.6 Units on a scale | Standard Deviation 44.17 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period | Mental Health | 12.0 Units on a scale | Standard Deviation 18.33 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period | Role Physical | 29.2 Units on a scale | Standard Deviation 48.3 |
Secondary
Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period
The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.
Time frame: Baseline; End of Week 6 (6 weeks)
Population: Intention to treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period | Physical Functioning | 14.1 Units on a scale | Standard Deviation 17.23 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period | Bodily Pain | 21.7 Units on a scale | Standard Deviation 21.39 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period | General Health | 6.3 Units on a scale | Standard Deviation 16.18 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period | Vitality | 8.0 Units on a scale | Standard Deviation 20.28 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period | Social Functioning | 10.7 Units on a scale | Standard Deviation 25.84 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period | Role Emotional | 14.8 Units on a scale | Standard Deviation 43.98 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period | Mental Health | 7.5 Units on a scale | Standard Deviation 18.22 |
| Tapentadol | Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period | Role Physical | 25.0 Units on a scale | Standard Deviation 40.47 |
Secondary
Clinical Global Impression of Change (All Participants) at End of Maintenance Period
In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.
Time frame: Baseline; End of Week 12 (12 weeks)
Population: Intention to treat (ITT).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Clinical Global Impression of Change (All Participants) at End of Maintenance Period | Very much improved | 17 participants |
| Tapentadol | Clinical Global Impression of Change (All Participants) at End of Maintenance Period | Much improved | 45 participants |
| Tapentadol | Clinical Global Impression of Change (All Participants) at End of Maintenance Period | Minimally improved | 22 participants |
| Tapentadol | Clinical Global Impression of Change (All Participants) at End of Maintenance Period | No change | 5 participants |
Secondary
Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period
In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.
Time frame: Baseline; End of Week 6 (6 weeks)
Population: Intention to treat (ITT).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period | Much worse | 1 participants |
| Tapentadol | Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period | Very much improved | 17 participants |
| Tapentadol | Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period | Much improved | 53 participants |
| Tapentadol | Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period | Minimally improved | 49 participants |
| Tapentadol | Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period | No change | 11 participants |
| Tapentadol | Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period | Minimally worse | 2 participants |
| Tapentadol | Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period | Very much worse | 1 participants |
Secondary
EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period
The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved.
Time frame: Baseline; End of Week 12 (12 weeks)
Population: Intention to treat (ITT). Unclear and positive painDETECT subpopulation - 66 participants. painDETECT negative subpopulation - 23 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period | All participants | 0.282 units on a scale | Standard Deviation 0.297 |
| Tapentadol | EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period | Participants painDETECT negative | 0.182 units on a scale | Standard Deviation 0.252 |
| Tapentadol | EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period | Participants painDETECT unclear or positive | 0.316 units on a scale | Standard Deviation 0.306 |
Secondary
EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period.
The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved.
Time frame: Baseline; End of Week 6 (6 weeks)
Population: Intention to treat (ITT). painDETECT negative subpopulation - 35 participants. Unclear and positive painDETECT subpopulation - 98 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period. | All participants | 0.244 Units on a scale | Standard Deviation 0.315 |
| Tapentadol | EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period. | Participants painDETECT negative | 0.229 Units on a scale | Standard Deviation 0.321 |
| Tapentadol | EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period. | Participant painDETECT unclear or positive | 0.249 Units on a scale | Standard Deviation 0.315 |
Secondary
Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period.
Tapentadol hydrochloride PR dose after 5 weeks of titration which was to be kept stable during the remained of the trial.
Time frame: Week 6
Population: Negative painDETECT subpopulation - 22 participants Unclear painDETECT subpopulation - 15 participants Positive painDETECT subpopulation - 22 participants Intention to treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period. | Negative painDETECT participants | 336.4 milligrams (mg) | Standard Deviation 132.9 |
| Tapentadol | Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period. | Unclear painDETECT participants | 293.3 milligrams (mg) | Standard Deviation 103.28 |
| Tapentadol | Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period. | Positive painDETECT participants | 268.2 milligrams (mg) | Standard Deviation 132.33 |
Secondary
Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period
Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A negative value indicates that there has been an improvement.
Time frame: Baseline; End of Week 12 (12 Weeks)
Population: Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants Intention to Treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period | All participants | -2.1 units on a scale | Standard Deviation 3.67 |
| Tapentadol | Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period | Negative painDETECT participants | -0.8 units on a scale | Standard Deviation 2.82 |
| Tapentadol | Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period | Unclear and positive painDETECT participants | -2.5 units on a scale | Standard Deviation 3.85 |
Secondary
Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period
Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A negative value indicates that there has been an improvement.
Time frame: Baseline; End of Week 6 (6 weeks)
Population: Negative painDETECT subpopulation - 34 participants Unclear and positive painDETECT subpopulation - 94 participants Intention to Treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period | All participants | -1.2 units on a scale | Standard Deviation 3.36 |
| Tapentadol | Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period | Negative painDETECT participants | -0.3 units on a scale | Standard Deviation 2.93 |
| Tapentadol | Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period | Unclear and positive painDETECT participants | -1.5 units on a scale | Standard Deviation 3.47 |
Secondary
Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period
Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A negative value indicates that there has been an improvement.
Time frame: Baseline; End of Week 12 (12 Weeks)
Population: Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants.~Intention to Treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period | All participants | -1.6 units on a scale | Standard Deviation 3.24 |
| Tapentadol | Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period | Negative painDETECT participants | -0.5 units on a scale | Standard Deviation 2.86 |
| Tapentadol | Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period | Unclear and positive painDETECT participants | -2.0 units on a scale | Standard Deviation 3.3 |
Secondary
Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period.
Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A negative value indicates that there has been an improvement.
Time frame: Baseline; End of Week 6 (6 weeks)
Population: Negative painDETECT subpopulation - 34 participants Unclear or positive painDETECT subpopulation - 94 participants Intention to Treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period. | All participants | -1.2 units on a scale | Standard Deviation 3.4 |
| Tapentadol | Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period. | Negative painDETECT participants | -1.0 units on a scale | Standard Deviation 3.15 |
| Tapentadol | Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period. | Unclear and positive painDETECT participants | -1.3 units on a scale | Standard Deviation 3.5 |
Secondary
Hospital Anxiety Depression Scale: Depression Score at Baseline
Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A negative value indicates that there has been an improvement.
Time frame: Baseline
Population: Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Hospital Anxiety Depression Scale: Depression Score at Baseline | All participants | 7.9 units on a scale | Standard Deviation 4.27 |
| Tapentadol | Hospital Anxiety Depression Scale: Depression Score at Baseline | Negative painDETECT participants | 6.5 units on a scale | Standard Deviation 3.96 |
| Tapentadol | Hospital Anxiety Depression Scale: Depression Score at Baseline | Unclear and positive painDETECT participants | 8.5 units on a scale | Standard Deviation 4.27 |
Secondary
Hospital Anxiety Depression Scale (HADS): Anxiety Score at Baseline
Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A negative value indicates that there has been an improvement.
Time frame: Baseline
Population: Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Hospital Anxiety Depression Scale (HADS): Anxiety Score at Baseline | All participants | 7.8 units on a scale | Standard Deviation 4.32 |
| Tapentadol | Hospital Anxiety Depression Scale (HADS): Anxiety Score at Baseline | Negative painDETECT participants | 6.2 units on a scale | Standard Deviation 4.1 |
| Tapentadol | Hospital Anxiety Depression Scale (HADS): Anxiety Score at Baseline | Unclear and positive painDETECT participants | 8.4 units on a scale | Standard Deviation 4.26 |
Secondary
Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline
Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.
Time frame: Baseline Visit
Population: Intention to treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline | Sub-score burning pain | 0.470 units on a scale | Standard Deviation 0.31 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline | Sub-score pressing pain | 0.549 units on a scale | Standard Deviation 0.243 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline | Sub-score paroxysmal pain | 0.575 units on a scale | Standard Deviation 0.243 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline | Sub-score evoked pain | 0.391 units on a scale | Standard Deviation 0.263 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline | Sub-score paresthesia / dysthesia | 0.539 units on a scale | Standard Deviation 0.273 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline | Overall score | 0.497 units on a scale | Standard Deviation 0.18 |
Secondary
Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period
Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.
Time frame: End of Week 12
Population: Intention to treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period | Sub-score burning pain | 0.180 units on a scale | Standard Deviation 0.237 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period | Sub-score pressing pain | 0.235 units on a scale | Standard Deviation 0.218 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period | Sub-score paroxysmal pain | 0.211 units on a scale | Standard Deviation 0.225 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period | Sub-score evoked pain | 0.175 units on a scale | Standard Deviation 0.188 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period | Sub-score paresthesia / dysthesia | 0.231 units on a scale | Standard Deviation 0.27 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period | Overall score | 0.206 units on a scale | Standard Deviation 0.198 |
Secondary
Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period
Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.
Time frame: End of Week 6
Population: Intention to treat (ITT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period | Sub-score burning pain | 0.260 units on a scale | Standard Deviation 0.281 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period | Sub-score pressing pain | 0.316 units on a scale | Standard Deviation 0.257 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period | Sub-score paroxysmal pain | 0.293 units on a scale | Standard Deviation 0.258 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period | Sub-score evoked pain | 0.230 units on a scale | Standard Deviation 0.221 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period | Sub-score paresthesia / dysthesia | 0.303 units on a scale | Standard Deviation 0.2722 |
| Tapentadol | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period | Overall score | 0.278 units on a scale | Standard Deviation 0.204 |
Secondary
NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period.
For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.
Time frame: End of Week 12
Population: Intention to treat (ITT). Negative painDETECT subpopulation - 8 participants. Unclear and positive painDETECT subpopulation - 42 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period. | Negative painDETECT participants | 3.4 Units on a scale | Standard Deviation 1.92 |
| Tapentadol | NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period. | Unclear and positive painDETECT participants | 3.2 Units on a scale | Standard Deviation 1.94 |
Secondary
NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.
For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.
Time frame: End of Week 6
Population: Intention to treat (ITT). Negative painDETECT subpopulation - 13 participants. Unclear and positive painDETECT subpopulation - 62 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period. | Negative painDETECT participants | 4.2 Units on a scale | Standard Deviation 1.96 |
| Tapentadol | NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period. | Unclear and positive painDETECT participants | 4.4 Units on a scale | Standard Deviation 2.26 |
Secondary
NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period.
For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.
Time frame: End of Week 12
Population: Intention to treat (ITT). Negative painDETECT subpopulation - 15 participants. Unclear and positive painDETECT subpopulation - 24 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period. | Negative painDETECT participants | 3.1 Units on a scale | Standard Deviation 1.81 |
| Tapentadol | NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period. | Unclear and positive painDETECT participants | 3.4 Units on a scale | Standard Deviation 2.32 |
Secondary
NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.
For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.
Time frame: End of Week 6
Population: Intention to treat (ITT). Negative painDETECT subpopulation - 22 participants. Unclear and positive painDETECT subpopulation - 37 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period. | Negative painDETECT participants | 4.0 Units on a scale | Standard Deviation 1.77 |
| Tapentadol | NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period. | Unclear and positive painDETECT participants | 4.1 Units on a scale | Standard Deviation 1.86 |
Secondary
painDETECT Assessment at Baseline
The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear.
Time frame: Baseline
Population: Intention to treat (ITT).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tapentadol | painDETECT Assessment at Baseline | 7.1 units on a scale | Standard Deviation 3.26 |
| Baseline painDETECT Unclear Group | painDETECT Assessment at Baseline | 13.2 units on a scale | Standard Deviation 3.36 |
| Baseline painDETECT Positive Group | painDETECT Assessment at Baseline | 21.4 units on a scale | Standard Deviation 5.05 |
Secondary
painDETECT Assessment for Participants at End of the Maintenance Period
The baseline painDETECT score was reassessed at the end of Week 12. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear.
Time frame: End of Week 12
Population: Intention to treat (ITT).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tapentadol | painDETECT Assessment for Participants at End of the Maintenance Period | 5.7 units on a scale | Standard Deviation 4.22 |
| Baseline painDETECT Unclear Group | painDETECT Assessment for Participants at End of the Maintenance Period | 7.1 units on a scale | Standard Deviation 6.13 |
| Baseline painDETECT Positive Group | painDETECT Assessment for Participants at End of the Maintenance Period | 11.2 units on a scale | Standard Deviation 7.52 |
Secondary
painDETECT Assessment for Participants at End of Titration and Optimal Dose Period
The baseline painDETECT score was reassessed at the end of Week 6. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear.
Time frame: End of Week 6
Population: Intention to treat (ITT).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tapentadol | painDETECT Assessment for Participants at End of Titration and Optimal Dose Period | 5.5 units on a scale | Standard Deviation 3.6 |
| Baseline painDETECT Unclear Group | painDETECT Assessment for Participants at End of Titration and Optimal Dose Period | 9.8 units on a scale | Standard Deviation 6.21 |
| Baseline painDETECT Positive Group | painDETECT Assessment for Participants at End of Titration and Optimal Dose Period | 14.4 units on a scale | Standard Deviation 7.05 |
Secondary
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period.
Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.
Time frame: End of Week 12
Population: Intention to treat (ITT).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period. | Excellent | 10 participants |
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period. | Very Good | 38 participants |
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period. | Good | 28 participants |
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period. | Fair | 11 participants |
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period. | Poor | 2 participants |
Secondary
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period.
Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.
Time frame: End of Week 6
Population: Intention to treat (ITT).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period. | Excellent | 12 participants |
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period. | Very Good | 29 participants |
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period. | Good | 64 participants |
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period. | Fair | 22 participants |
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period. | Poor | 7 participants |
Secondary
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period.
Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.
Time frame: End of Week 8
Population: Intention to treat (ITT).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period. | Good | 58 participants |
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period. | Fair | 17 participants |
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period. | Poor | 3 participants |
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period. | Excellent | 14 participants |
| Tapentadol | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period. | Very Good | 30 participants |
Secondary
Participant's Satisfaction With Previous Analgesic Treatment at Baseline
Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous analgesic medication was rated as excellent, very good, good, fair and poor.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Participant's Satisfaction With Previous Analgesic Treatment at Baseline | Good | 2 participants |
| Tapentadol | Participant's Satisfaction With Previous Analgesic Treatment at Baseline | Fair | 98 participants |
| Tapentadol | Participant's Satisfaction With Previous Analgesic Treatment at Baseline | Poor | 75 participants |
Secondary
Patient Global Impression of Change at End of the Maintenance Period
In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.
Time frame: Baseline; End of Week 12 (12 weeks)
Population: Intention to treat (ITT).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Patient Global Impression of Change at End of the Maintenance Period | Very much improved | 19 participants |
| Tapentadol | Patient Global Impression of Change at End of the Maintenance Period | Much improved | 42 participants |
| Tapentadol | Patient Global Impression of Change at End of the Maintenance Period | Minimally improved | 23 participants |
| Tapentadol | Patient Global Impression of Change at End of the Maintenance Period | No change | 5 participants |
| Tapentadol | Patient Global Impression of Change at End of the Maintenance Period | Minimally worse | 0 participants |
| Tapentadol | Patient Global Impression of Change at End of the Maintenance Period | Very much worse | 0 participants |
| Tapentadol | Patient Global Impression of Change at End of the Maintenance Period | Much worse | 0 participants |
Secondary
Patient Global Impression of Change at End of Titration and Optimal Dose Period
In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.
Time frame: Baseline; End of Week 6 (6 Weeks)
Population: Intention to treat (ITT).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Patient Global Impression of Change at End of Titration and Optimal Dose Period | Very much improved | 12 participants |
| Tapentadol | Patient Global Impression of Change at End of Titration and Optimal Dose Period | Much improved | 55 participants |
| Tapentadol | Patient Global Impression of Change at End of Titration and Optimal Dose Period | Minimally improved | 49 participants |
| Tapentadol | Patient Global Impression of Change at End of Titration and Optimal Dose Period | No change | 10 participants |
| Tapentadol | Patient Global Impression of Change at End of Titration and Optimal Dose Period | Minimally worse | 5 participants |
| Tapentadol | Patient Global Impression of Change at End of Titration and Optimal Dose Period | Much worse | 2 participants |
| Tapentadol | Patient Global Impression of Change at End of Titration and Optimal Dose Period | Very much worse | 1 participants |