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
Primary Purpose
Pain, Chronic Pain, Low Back Pain
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tapentadol Prolonged Release
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring pain assessment, tapentadol, centrally acting analgesic
Eligibility 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.
Sites / Locations
- BE004
- BE003
- BE002
- BE001
- CZ001
- FR004
- FR001
- DE005
- DE001
- DE003
- DE006
- DE004
- DE008
- DE007
- NL002
- NL004
- NL003
- NL001
- PL002
- PL001
- ES006
- ES001
- ES003
- ES004
- ES005
- CH001
- CH002
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tapentadol Prolonged Release
Arm Description
Other Names: Nucynta Palexia
Outcomes
Primary Outcome Measures
Number of Participants That Responded to Treatment
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
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.
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.
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
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
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00986258
Brief Title
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
Official Title
An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Severe Chronic Nociceptive, Mixed or Neuropathic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
This clinical trial was terminated early, due to slow recruitment and study drug shortages.
Study Start Date
October 30, 2009 (Actual)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Pain, Low Back Pain, Neuropathic Pain, Nociceptive Pain
Keywords
pain assessment, tapentadol, centrally acting analgesic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tapentadol Prolonged Release
Arm Type
Experimental
Arm Description
Other Names:
Nucynta
Palexia
Intervention Type
Drug
Intervention Name(s)
Tapentadol Prolonged Release
Other Intervention Name(s)
- Nucynta, - Palexia
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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)
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)
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)
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)
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)
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)
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
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
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
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)
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)
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)
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)
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)
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Schäfer, Prof. MD
Organizational Affiliation
Charité University Berlin, Campus Virchow Klinikum
Official's Role
Principal Investigator
Facility Information:
Facility Name
BE004
City
Brugge
Country
Belgium
Facility Name
BE003
City
Charleroi
Country
Belgium
Facility Name
BE002
City
Edegem
Country
Belgium
Facility Name
BE001
City
Liège
Country
Belgium
Facility Name
CZ001
City
Brno
Country
Czechia
Facility Name
FR004
City
Thionville
Country
France
Facility Name
FR001
City
Toulouse
Country
France
Facility Name
DE005
City
Albstadt
Country
Germany
Facility Name
DE001
City
Berlin
Country
Germany
Facility Name
DE003
City
Berlin
Country
Germany
Facility Name
DE006
City
Kiel
Country
Germany
Facility Name
DE004
City
Leipzig
Country
Germany
Facility Name
DE008
City
Leipzig
Country
Germany
Facility Name
DE007
City
Stuttgart
Country
Germany
Facility Name
NL002
City
Alkmaar
Country
Netherlands
Facility Name
NL004
City
Doetinchem
Country
Netherlands
Facility Name
NL003
City
Eindhoven
Country
Netherlands
Facility Name
NL001
City
Tiel
Country
Netherlands
Facility Name
PL002
City
Krakow
Country
Poland
Facility Name
PL001
City
Poznan
Country
Poland
Facility Name
ES006
City
Cadiz
Country
Spain
Facility Name
ES001
City
Granada
Country
Spain
Facility Name
ES003
City
Malaga
Country
Spain
Facility Name
ES004
City
Sevilla
Country
Spain
Facility Name
ES005
City
Valencia
Country
Spain
Facility Name
CH001
City
Basel
Country
Switzerland
Facility Name
CH002
City
St. Gallen
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Information available on the Grünenthal Web Site.
IPD Sharing URL
http://www.grunenthal.com/r-d-vision-mission/clinical-trials/data-sharing-clinical-trials
Citations:
PubMed Identifier
23475406
Citation
Galvez R, Schafer M, Hans G, Falke D, Steigerwald I. Tapentadol prolonged release versus strong opioids for severe, chronic low back pain: results of an open-label, phase 3b study. Adv Ther. 2013 Mar;30(3):229-59. doi: 10.1007/s12325-013-0015-6. Epub 2013 Mar 7.
Results Reference
result
Learn more about this trial
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
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