NCT00986258终止3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 136
- 试验地点
- 27
- 主要终点
- Number of Participants That Responded to Treatment
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 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.
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 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).
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:
- •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.
研究组 & 干预措施
Tapentadol Prolonged Release
Experimental
Other Names:
- Nucynta
- Palexia
干预措施: Tapentadol Prolonged Release (Drug)
结局指标
主要结局
Number of Participants That Responded to Treatment
时间窗: 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.
次要结局
- Average Pain Intensity Before the Start of Tapentadol Treatment(Baseline)
- Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment.(Baseline; End of Week 6 (6 weeks))
- Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment.(Baseline; End of Week 12 (12 weeks))
- Patient Global Impression of Change(Baseline; End of Week 12 (12 Weeks))
- Change in the Health Survey Scores Form (SF-36)(Baseline; End of Week 12 (12 Weeks))
- Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score(End of Week 12)
- Mean Equipotency Ratio of Tapentadol Compared to Oxycodone(Baseline; End of Week 6 (6 Weeks))
- Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine(Baseline; End of Week 6 (6 Weeks))
- Mean Equipotency Ratio of Tapentadol Compared to Fentanyl(Baseline; End of Week 6 (6 Weeks))
- Mean Equipotency Ratio of Tapentadol Compared to Morphine(Baseline; End of Week 6 (6 Weeks))
- Mean Equipotency Ratio of Tapentadol Compared to Hydromorphone(Baseline; End of Week 6 (6 Weeks))
- painDETECT Assessment at Baseline(Baseline)
- painDETECT Assessment for Participants After 6 Weeks of Tapentadol Prolonged Release Treatment(End of Week 6)
- painDETECT Assessment for Participants After 12 Weeks of Tapentadol Prolonged Release Treatment(End of Week 12)
研究者
研究点 (27)
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