Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability
Study Details
Study Description
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 WHO Step III analgesics and show lack of tolerability. 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 (WHO Step III) with that of tapentadol hydrochloride prolonged release treatment during defined periods of evaluation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tapentadol Prolonged Release Other Names: Nucynta Palexia |
Drug: Tapentadol Prolonged Release
Participants started with 50 mg, 100 mg or 150 mg tapentadol prolonged release (PR) twice daily. Opioid rotation to tapentadol was scheduled as follows:
if less than 100 mg morphine equivalent start with 50 mg tapentadol PR;
if on 101 to 160 mg morphine equivalent daily dose start with 100 mg tapentadol PR;
if above 161 mg morphine equivalent daily dose start with 150 mg tapentadol PR.
Tapentadol doses were adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis). After 5 weeks, the doses of tapentadol PR were kept stable (start of Maintenance phase). The tapentadol PR formulation was administered for up to 12 weeks. Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol PR was reached.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants That Responded to Treatment [6 weeks]
Participants were considered responders if they reported the same or less average pain intensity over a 3 day period (NRS-3) after 6 weeks of tapentadol prolonged release treatment compared to their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1.
Secondary Outcome Measures
- Average Pain Intensity Before the Start of Tapentadol Treatment [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".
- Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment. [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 value on the 0 to 10 scale. A negative value indicates a reduction in pain intensity from the baseline average pain intensity.
- Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment. [Baseline; End of Week 12 (12 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 value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity.
- Patient Global Impression of Change [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.
- Patient Global Impression of Change [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) [Baseline; End of Week 6 (6 Weeks)]
The Scores Form 36 (SF-36) includes several brief 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) [Baseline; End of Week 12 (12 Weeks)]
The Scores Form 36 (SF-36) includes several brief 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.
- Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score [Baseline]
All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant. Results are reported as the mean for each neuropathic symptom in the sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group).
- Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score [End of Week 6]
All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant. Results are reported as the mean for each neuropathic symptom in a sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group).
- Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score [End of Week 12]
All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant. Results are reported as the mean (average) for each neuropathic symptom in a sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group).
- Mean Equipotency Ratio of Tapentadol Compared to Oxycodone [Baseline; End of Week 6 (6 Weeks)]
Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone.
- Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine [Baseline; End of Week 6 (6 Weeks)]
Tapentadol was compared to Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Buprenorphine.
- Mean Equipotency Ratio of Tapentadol Compared to Fentanyl [Baseline; End of Week 6 (6 Weeks)]
Tapentadol was compared to Transdermal Fentanyl with Fentanyl set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Fentanyl was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Fentanyl.
- Mean Equipotency Ratio of Tapentadol Compared to Morphine [Baseline; End of Week 6 (6 Weeks)]
Tapentadol was compared to Morphine with Morphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Morphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Morphine.
- Mean Equipotency Ratio of Tapentadol Compared to Hydromorphone [Baseline; End of Week 6 (6 Weeks)]
Tapentadol was compared to Hydromorphone with Hydromorphone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Hydromorphone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Hydromorphone.
- 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 After 6 Weeks of Tapentadol Prolonged Release Treatment [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 After 12 Weeks of Tapentadol Prolonged Release Treatment [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".
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants must have signed an Informed Consent Form indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it.
-
Participants are men or non-pregnant, non-lactating women. Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. 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.
-
Participant's pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator.
-
Participants must be taking a WHO Step III analgesic on a daily basis for at least 3 months prior to the Screening Visit.
-
Participants must have responded to the WHO Step III analgesic, i.e., participants must have a confirmed average pain intensity score (NRS 3) of ≤5 points during the last 3 days prior to the Screening Visit.
-
Participants must report opioid-related side effects as the reason to change their analgesic.
-
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).
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:
-
Subjects with acute or severe bronchial asthma or hypercapnia.
-
Subjects 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 concomitant painful condition other than low back pain that could confound the subject's trial assessments or self evaluation of pain, e.g., anatomical deformities, significant skin conditions such as abscess or syndromes with widespread pain such as fibromyalgia.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | BE004 | Brugge | Belgium | ||
| 2 | BE003 | Charleroi | Belgium | ||
| 3 | BE002 | Edegem | Belgium | ||
| 4 | BE001 | Liège | Belgium | ||
| 5 | CZ001 | Brno | Czechia | ||
| 6 | FR004 | Thionville | France | ||
| 7 | FR001 | Toulouse | France | ||
| 8 | DE005 | Albstadt | Germany | ||
| 9 | DE001 | Berlin | Germany | ||
| 10 | DE003 | Berlin | Germany | ||
| 11 | DE006 | Kiel | Germany | ||
| 12 | DE004 | Leipzig | Germany | ||
| 13 | DE008 | Leipzig | Germany | ||
| 14 | DE007 | Stuttgart | Germany | ||
| 15 | NL002 | Alkmaar | Netherlands | ||
| 16 | NL004 | Doetinchem | Netherlands | ||
| 17 | NL003 | Eindhoven | Netherlands | ||
| 18 | NL001 | Tiel | Netherlands | ||
| 19 | PL002 | Krakow | Poland | ||
| 20 | PL001 | Poznan | Poland | ||
| 21 | ES006 | Cadiz | Spain | ||
| 22 | ES001 | Granada | Spain | ||
| 23 | ES003 | Malaga | Spain | ||
| 24 | ES004 | Sevilla | Spain | ||
| 25 | ES005 | Valencia | Spain | ||
| 26 | CH001 | Basel | Switzerland | ||
| 27 | CH002 | St. Gallen | Switzerland |
Sponsors and Collaborators
- Grünenthal GmbH
Investigators
- Principal Investigator: Michael Schäfer, Prof. MD, Charité University Berlin, Campus Virchow Klinikum
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 835093
- 2009-010428-25
- KF5503/45
Study Results
Participant Flow
| Recruitment Details | The enrollment of the first participant was on the 30 October 2009 and was prematurely terminated, due to slow recruitment, on 21 January 2011 (when the last subject completed the last follow-up examination). |
|---|---|
| Pre-assignment Detail | The Trial had a duration of 13 weeks. The one week Observation Period did not involve dosing with Tapentadol. For Tapentadol analyses purposes the first 6 weeks of dosing with Tapentadol are reported as one period, Titration and Optimal Dose Period. The last 6 weeks on Tapentadol are reported as the Maintenance Period. |
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks.Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Period Title: Observation Period | |
| STARTED | 136 |
| COMPLETED | 125 |
| NOT COMPLETED | 11 |
| Period Title: Observation Period | |
| STARTED | 125 |
| COMPLETED | 102 |
| NOT COMPLETED | 23 |
| Period Title: Observation Period | |
| STARTED | 102 |
| COMPLETED | 93 |
| NOT COMPLETED | 9 |
Baseline Characteristics
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Overall Participants | 125 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
57.1
(12.00)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
76
60.8%
|
| Male |
49
39.2%
|
| Region of Enrollment (participants) [Number] | |
| France |
1
0.8%
|
| Czechia |
24
19.2%
|
| Spain |
21
16.8%
|
| Poland |
9
7.2%
|
| Belgium |
17
13.6%
|
| Netherlands |
14
11.2%
|
| Germany |
34
27.2%
|
| Switzerland |
5
4%
|
Outcome Measures
| Title | Number of Participants That Responded to Treatment |
|---|---|
| Description | Participants were considered responders if they reported the same or less average pain intensity over a 3 day period (NRS-3) after 6 weeks of tapentadol prolonged release treatment compared to their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol Set. Last Observation Carried Forward (LOCF). |
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 94 |
| Number [participants] |
76
60.8%
|
| Title | Average Pain Intensity Before the Start of Tapentadol Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to Treat |
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 122 |
| Mean (Standard Deviation) [units on a scale] |
4.8
(0.75)
|
| Title | Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment. |
|---|---|
| Description | 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 value on the 0 to 10 scale. A negative value indicates a reduction in pain intensity from the baseline average pain intensity. |
| Time Frame | Baseline; End of Week 6 (6 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT) |
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 101 |
| Mean (Standard Deviation) [units on a scale] |
-0.9
(1.89)
|
| Title | Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment. |
|---|---|
| Description | 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 value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity. |
| Time Frame | Baseline; End of Week 12 (12 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT). |
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 93 |
| Mean (Standard Deviation) [units on a scale] |
-1.3
(2.10)
|
| Title | Patient Global Impression of Change |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT) |
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 101 |
| Very much improved |
5
4%
|
| Much improved |
29
23.2%
|
| Minimally improved |
47
37.6%
|
| No change |
11
8.8%
|
| Minimally worse |
6
4.8%
|
| Much worse |
3
2.4%
|
| Very much worse |
0
0%
|
| Title | Patient Global Impression of Change |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT) |
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 93 |
| Very much improved |
9
7.2%
|
| Much improved |
34
27.2%
|
| Minimally improved |
38
30.4%
|
| No change |
9
7.2%
|
| Minimally worse |
2
1.6%
|
| Much worse |
1
0.8%
|
| Very much worse |
0
0%
|
| Title | Change in the Health Survey Scores Form (SF-36) |
|---|---|
| Description | The Scores Form 36 (SF-36) includes several brief 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT). For the sub-scores "Role Emotional" and "Role Physical" there were 98 participants, for sub-scores "Physical Functioning", "Vitality" and "Mental Health" there were 99 participants, for sub-score "General Health" there were 100 participants with data available for the change of these sub-scores from baseline to visit 6. |
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 101 |
| Physical Functioning |
8.4
(18.65)
|
| Bodily Pain |
11.6
(20.00)
|
| General Health |
5.9
(15.10)
|
| Vitality |
9.2
(17.44)
|
| Social Functioning |
8.0
(24.47)
|
| Role Emotional |
-1.4
(42.26)
|
| Mental Health |
5.1
(16.73)
|
| Role Physical |
6.9
(28.89)
|
| Title | Change in the Health Survey Scores Form (SF-36) |
|---|---|
| Description | The Scores Form 36 (SF-36) includes several brief 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to Treat (ITT). For the sub-scores "Role Emotional" and "Role Physical", there were only 91 participants with data available for the change of these sub-scores from baseline to visit 12. |
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 93 |
| Physical Functioning |
10.5
(19.96)
|
| Bodily Pain |
14.1
(22.84)
|
| General Health |
5.7
(14.98)
|
| Vitality |
12.0
(21.03)
|
| Social Functioning |
11.7
(27.07)
|
| Role Emotional |
13.9
(43.06)
|
| Mental Health |
9.8
(17.70)
|
| Role Physical |
10.7
(31.65)
|
| Title | Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score |
|---|---|
| Description | All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant. Results are reported as the mean for each neuropathic symptom in the sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group). |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT). For the sub-scores "Overall Score" and "Pressing Pain" there were only 69 participants with data available at baseline. |
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 71 |
| Sub-score burning pain |
0.41
(0.284)
|
| Sub-score pressing pain |
0.405
(0.23)
|
| Sub-score paroxysmal pain |
0.422
(0.221)
|
| Sub-score evoked pain |
0.385
(0.216)
|
| Sub-score paresthesia / dysthesia |
0.424
(0.233)
|
| Overall score |
0.408
(0.158)
|
| Title | Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score |
|---|---|
| Description | All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant. Results are reported as the mean for each neuropathic symptom in a sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group). |
| Time Frame | End of Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT). For the sub-scores "Overall Score" and "Pressing Pain" there were only 60 participants with data available at Visit 6. |
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 61 |
| Sub-score burning pain |
0.32
(0.273)
|
| Sub-score pressing pain |
0.322
(0.229)
|
| Sub-score paroxysmal pain |
0.271
(0.231)
|
| Sub-score evoked pain |
0.274
(0.216)
|
| Sub-score paresthesia / dysthesia |
0.302
(0.21)
|
| Overall score |
0.297
(0.178)
|
| Title | Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score |
|---|---|
| Description | All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant. Results are reported as the mean (average) for each neuropathic symptom in a sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group). |
| Time Frame | End of Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT). |
| Arm/Group Title | Tapentadol Prolonged Release |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 56 |
| Sub-score burning pain |
0.27
(0.281)
|
| Sub-score pressing pain |
0.302
(0.235)
|
| Sub-score paroxysmal pain |
0.254
(0.255)
|
| Sub-score evoked pain |
0.273
(0.252)
|
| Sub-score paresthesia / dysthesia |
0.299
(0.239)
|
| Overall score |
0.280
(0.211)
|
| Title | Mean Equipotency Ratio of Tapentadol Compared to Oxycodone |
|---|---|
| Description | Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone. |
| Time Frame | Baseline; End of Week 6 (6 Weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT). 35 participants with previous oxycodone treatment. |
| Arm/Group Title | Tapentadol |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 35 |
| Number [Ratio] |
5.3
|
| Title | Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine |
|---|---|
| Description | Tapentadol was compared to Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Buprenorphine. |
| Time Frame | Baseline; End of Week 6 (6 Weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT). 24 participants with previous buprenorphine treatment. |
| Arm/Group Title | Tapentadol |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 24 |
| Number [Ratio] |
210.0
|
| Title | Mean Equipotency Ratio of Tapentadol Compared to Fentanyl |
|---|---|
| Description | Tapentadol was compared to Transdermal Fentanyl with Fentanyl set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Fentanyl was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Fentanyl. |
| Time Frame | Baseline; End of Week 6 (6 Weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat (ITT). 22 participants with previous transdermal fentanyl treatment. |
| Arm/Group Title | Tapentadol |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 22 |
| Number [Ratio] |
250.7
|
| Title | Mean Equipotency Ratio of Tapentadol Compared to Morphine |
|---|---|
| Description | Tapentadol was compared to Morphine with Morphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Morphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Morphine. |
| Time Frame | Baseline; End of Week 6 (6 Weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat (ITT). 14 participants with previous morphine treatment. |
| Arm/Group Title | Tapentadol |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 14 |
| Number [Ratio] |
3.0
|
| Title | Mean Equipotency Ratio of Tapentadol Compared to Hydromorphone |
|---|---|
| Description | Tapentadol was compared to Hydromorphone with Hydromorphone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Hydromorphone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Hydromorphone. |
| Time Frame | Baseline; End of Week 6 (6 Weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT). 8 participants with previous hydromorphone treatment. |
| Arm/Group Title | Tapentadol |
|---|---|
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached. |
| Measure Participants | 8 |
| Number [Ratio] |
10.5
|
| Title | painDETECT Assessment at Baseline |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT). |
| Arm/Group Title | Baseline painDETECT Negative Group | Baseline painDETECT Unclear Group | Baseline painDETECT Positive Group |
|---|---|---|---|
| Arm/Group Description | Subgroup of participants with a score between 0 and 12. | Subgroup of participants with a score between 13 and 18. | Subgroup of participants with a score between 19 and 38. |
| Measure Participants | 44 | 24 | 50 |
| Mean (Standard Deviation) [units on a scale] |
6.5
(3.90)
|
14.7
(2.39)
|
21.1
(3.39)
|
| Title | painDETECT Assessment for Participants After 6 Weeks of Tapentadol Prolonged Release Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT). |
| Arm/Group Title | Baseline painDETECT Negative Group | Baseline painDETECT Unclear Group | Baseline painDETECT Positive Group |
|---|---|---|---|
| Arm/Group Description | The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6. | The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6. | The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6. |
| Measure Participants | 35 | 20 | 45 |
| Mean (Standard Deviation) [units on a scale] |
7.5
(4.18)
|
10.5
(4.75)
|
17.4
(5.95)
|
| Title | painDETECT Assessment for Participants After 12 Weeks of Tapentadol Prolonged Release Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT). |
| Arm/Group Title | Baseline painDETECT Negative Group | Baseline painDETECT Unclear Group | Baseline painDETECT Positive Group |
|---|---|---|---|
| Arm/Group Description | The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12. | The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12. | The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12. |
| Measure Participants | 33 | 19 | 40 |
| Mean (Standard Deviation) [units on a scale] |
6.8
(4.85)
|
8.6
(5.43)
|
16.5
(7.17)
|
Adverse Events
| Time Frame | In total, subjects were to be treated for up to 12 weeks with tapentadol. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Tapentadol Prolonged Release | |
| Arm/Group Description | All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 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 immediate release once 500 mg tapentadol prolonged release dose was reached. | |
All Cause Mortality |
||
| Tapentadol Prolonged Release | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Tapentadol Prolonged Release | ||
| Affected / at Risk (%) | # Events | |
| Total | 11/125 (8.8%) | |
| Cardiac disorders | ||
| Cardiac failure | 1/125 (0.8%) | |
| Myocardial infarction | 1/125 (0.8%) | |
| Trachycardia | 1/125 (0.8%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/125 (0.8%) | |
| General disorders | ||
| Chest pain | 1/125 (0.8%) | |
| Drug withdrawal syndrome | 2/125 (1.6%) | |
| Oedema | 1/125 (0.8%) | |
| Infections and infestations | ||
| pneumonia | 1/125 (0.8%) | |
| Musculoskeletal and connective tissue disorders | ||
| Intervertebral disc protrusion | 1/125 (0.8%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Bladder cancer | 1/125 (0.8%) | |
| Nervous system disorders | ||
| Headache | 1/125 (0.8%) | |
| Subarachnoid haemorrhage | 1/125 (0.8%) | |
| Renal and urinary disorders | ||
| Calculus urinary | 1/125 (0.8%) | |
| Nephrolithiasis | 1/125 (0.8%) | |
| Vascular disorders | ||
| Haematoma | 1/125 (0.8%) | |
| Hypertension | 1/125 (0.8%) | |
Other (Not Including Serious) Adverse Events |
||
| Tapentadol Prolonged Release | ||
| Affected / at Risk (%) | # Events | |
| Total | 85/125 (68%) | |
| Gastrointestinal disorders | ||
| Abdominal pain upper | 7/125 (5.6%) | |
| Constipation | 15/125 (12%) | |
| Diarrhoea | 13/125 (10.4%) | |
| Dry mouth | 8/125 (6.4%) | |
| Nausea | 19/125 (15.2%) | |
| General disorders | ||
| Drug Withdrawal Syndrome | 26/125 (20.8%) | |
| Fatigue | 13/125 (10.4%) | |
| Nervous system disorders | ||
| Dizziness | 16/125 (12.8%) | |
| Headache | 18/125 (14.4%) | |
| Psychiatric disorders | ||
| Insomnia | 16/125 (12.8%) | |
| Skin and subcutaneous tissue disorders | ||
| Hyperhidrosis | 10/125 (8%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Grünenthal reserves the right to review any publication pertaining to the trial before it is submitted for publication. Neither party has the right to prohibit publication unless publication can be shown to affect possible patent rights.
Results Point of Contact
| Name/Title | Director of Clinical Trials |
|---|---|
| Organization | Grünenthal GmbH |
| Phone | +49 241 569 3223 |
| clinical-trials@grunenthal.com |
- 835093
- 2009-010428-25
- KF5503/45