NCT00983385已完成3 期
An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Uncontrolled Severe Chronic Nociceptive, Mixed or Neuropathic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 8
- 主要终点
- The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline).
研究概览
简要总结
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.
The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have signed an Informed Consent Form.
- •Participants were men or non-pregnant, non-lactating women. Female participants must be postmenopausal, surgically sterile, or practicing an effective method of birth control. Women of childbearing potential must have a negative pregnancy test at screening.
- •Participants must be appropriately communicative to verbalize and to differentiate with regard to location and intensity of the pain.
- •Participants must be at least 18 years of age.
- •Participants must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months.
- •If the participant has radicular pain, this must have been present for at least 3 months and stable for the 4 weeks before enrollment.
- •Participants's pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator.
- •Participants must report a rate of satisfaction with their previous analgesic regimen not exceeding "fair" on a subject satisfaction with treatment scale (5-point VRS).
- •If under regular, daily pretreatment:
- •Participants must be taking a WHO Step I or Step II analgesic medication on a daily basis for at least 2 weeks prior to the Screening Visit.
- •The Investigator considers dose increase of WHO Step I analgesics (as mono- or combination therapy) and/or continuation with or dose increase of WHO Step II analgesics inadequate for the individual participant, whatever applicable.
- •Participants must have an average pain intensity score (NRS 3) greater than 5 points during the last 3 days prior to the Screening Visit. or
- •If no regular analgesic pretreatment is reported:
- •Participants must have an average pain intensity score (NRS-3) greater than 6 points in the last 3 days prior to the Screening Visit and related to low back pain.
排除标准
- •Presence of a clinically significant disease or laboratory findings that in the Investigator's opinion may affect efficacy or safety assessments.
- •Presence of active systemic or local infection that may, in the opinion of the Investigator, affect the efficacy, quality of life/function or safety assessments.
- •History of alcohol or drug abuse, or suspicion of in Investigator's judgement.
- •Presence of concomitant autoimmune inflammatory conditions.
- •Known history of or laboratory values reflecting severe renal impairment.
- •Known history of moderately or severely impaired hepatic function.
- •History of or active hepatitis B or C within the past 3 months or history of HIV infection
- •History of seizure disorder or epilepsy.
- •Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post-traumatic amnesia lasting more than 24 h) or residual sequelae suggesting transient changes in consciousness.
- •Pregnant or breast-feeding.
- •History of allergy to, or hypersensitivity to tapentadol hydrochloride or its excipients, or contraindications related to tapentadol hydrochloride including:
- •Participants with acute or severe bronchial asthma or hypercapnia.
- •Participants who have or are suspected of having paralytic ileus.
- •Employees of the Investigator or trial site, with direct involvement in this trial or other trials under the direction of the Investigator or trial site, as well as family members of employees of the Investigator.
- •Participation in another trial concurrently or within 4 weeks prior to the Screening Visit.
- •Known to or suspected of not being able to comply with the protocol and the use of the investigational medicinal product.
- •Use of monoamine oxidase inhibitors within 14 days before the Screening Visit.
- •Non-stable dosing of selective serotonin reuptake inhibitors within 30 days before the Screening Visit (the doses must remain stable during the trial).
- •Presence of conditions other than low back pain that could confound the assessment or self evaluation of pain, e.g., anatomical deformities, significant skin conditions such as abscess or syndromes with widespread pain such as fibromyalgia.
- •Any concomitant painful condition that could interfere with the subject's trial assessments or with their ability to differentiate low back pain from other painful conditions.
- •Any painful procedures during the trial (e.g., major surgery) that may, in the opinion of the Investigator, affect the efficacy or safety assessments.
- •Pending litigation due to chronic pain or disability.
- •Intake of Step III analgesics within the 30 days prior to the Screening Visit.
研究组 & 干预措施
Tapentadol
Experimental
Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol immediate release (IR) tablets per day, with a minimum of a 4 hour interval between doses, were taken if there were acute pain episodes. The total daily dose of Tapentadol PR and IR were not permitted to exceed 500 mg per day.
干预措施: Tapentadol PR (Drug)
Tapentadol
Experimental
Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol immediate release (IR) tablets per day, with a minimum of a 4 hour interval between doses, were taken if there were acute pain episodes. The total daily dose of Tapentadol PR and IR were not permitted to exceed 500 mg per day.
干预措施: Observation period (Other)
结局指标
主要结局
The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline).
时间窗: Baseline; End of Week 6 (6 Weeks)
For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity.
次要结局
- Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period(Baseline; End of Week 12 (12 weeks))
- painDETECT Assessment at Baseline(Baseline)
- Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline(Baseline Visit)
- Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period(End of Week 6)
- Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period(End of Week 12)
- Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of Titration and Optimal Dose Period(Baseline; End of Week 6 (6 Weeks))
- Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of the Maintenance Period(Baseline; End of Week 12 (12 Weeks))
- Patient Global Impression of Change at End of Titration and Optimal Dose Period(Baseline; End of Week 6 (6 Weeks))
- Patient Global Impression of Change at End of the Maintenance Period(Baseline; End of Week 12 (12 weeks))
- EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period.(Baseline; End of Week 6 (6 weeks))
- Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period.(Baseline; End of Week 6 (6 weeks))
- Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period(Baseline; End of Week 6 (6 weeks))
- painDETECT Assessment for Participants at End of Titration and Optimal Dose Period(End of Week 6)
- painDETECT Assessment for Participants at End of the Maintenance Period(End of Week 12)
- EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period(Baseline; End of Week 12 (12 weeks))
- Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period(Baseline; End of Week 12 (12 weeks))
- Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period(Baseline; End of Week 6 (6 weeks))
- Clinical Global Impression of Change (All Participants) at End of Maintenance Period(Baseline; End of Week 12 (12 weeks))
- Hospital Anxiety Depression Scale (HADS): Anxiety Score at Baseline(Baseline)
- Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period(Baseline; End of Week 6 (6 weeks))
- Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period(Baseline; End of Week 12 (12 Weeks))
- Hospital Anxiety Depression Scale: Depression Score at Baseline(Baseline)
- Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period.(Week 6)
- Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period.(Baseline; End of Week 6 (6 weeks))
- Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period(Baseline; End of Week 12 (12 Weeks))
- Participant's Satisfaction With Previous Analgesic Treatment at Baseline(Baseline)
- Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period.(End of Week 6)
- NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period.(End of Week 12)
- Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period.(End of Week 8)
- Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period.(End of Week 12)
- Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline.(Baseline)
- NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.(End of Week 6)
- Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline.(Baseline)
- NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.(End of Week 6)
- NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period.(End of Week 12)
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