EUCTR2012-001920-36-DE进行中（未招募）不适用
Efficacy, safety, and tolerability of GRT6005 in subjects with moderate to severe chronic low back pain - n.a.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female subject 18 years to 80 years of age at Visit 1.
- •Documented clinical diagnosis of chronic LBP of non-malignant origin and pain present for at least 3 months.
- •Average 24 hour pain =5 on an 11 point NRS during the 3 days prior to Visit 3 without the use of rescue medication. Subjects must have 3 out of three 24 hour pain assessments during this 3 day period.
- •Subjects must be on stable analgesic medications (non-opioid and/or opioid medications) for their chronic LBP with regular intake (i.e., at least 4 days per week) for at least 3 months prior to Visit 1 according to their medical history and dissatisfied with current analgesic treatment.
- •Subjects requiring opioid treatment must be taking daily doses of opioid-based analgesic equivalent to =160 mg of oral morphine.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 480
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Female subjects who are pregnant or are breastfeeding.
- •Any clinically significant disease or laboratory findings that in the
- •investigator's opinion may affect efficacy or safety assessments or may compromise the subject's safety during trial participation
- •Subjects with moderate to severe functional hepatic impairment corresponding to Child-Pugh classification B and C. Subjects with impaired hepatic cellular integrity.
- •History of acute hepatitis within 3 months of Visit 1 or chronic hepatitis or a positive result on anti-hepatitis A IgM antibody within 6 months of Visit 1, hepatitis B surface antigen, or anti–hepatitis C antibody. History of human immunodeficiency virus (HIV) infection.
- •Subjects with impaired renal function.
- •History of any major gastrointestinal prior procedures or
- •gastrointestinal conditions that might affect the absorption or
- •metabolism of GRT6005.
- •Presence of risk factors for Torsade de Pointes
- •Presence of QTcF >450 ms at Visit 1.
- •History of seizure disorder and/or epilepsy or any condition associated with a significant risk for seizure disorder or epilepsy
- •History or presence of malignancy, with the exception of curative
- •treated subjects or subjects being in remission of cancer for at least 2 years and not requiring treatment.
- •Subjects with chronic LBP potentially associated with a specific spinal cause
- •Subjects with >1 previous low back surgeries or recent low-back
- •surgery (within the last 12 months) or scheduled low back surgery
- •during the trial or any other scheduled surgery or painful procedure during the course of the trial that, in the opinion of the investigator, may affect efficacy or safety assessments.
- •Any invasive procedures aimed to reduce LBP (e.g., epidural injections, facet joint or sacroiliac joint blocks) within the past 3 months and throughout the trial.
- •Subjects with any kind of neuromodulation
- •Clinically relevant history of hypersensitivity, allergy or
- •contraindications to any of the IMPs' excipients,
- •paracetamol/acetaminophen, tapentadol HCl, or opioid analgesics (or excipients).
- •Presence of conditions other than LBP that could confound the
- •assessment or self-evaluation of pain.
- •Increased intracranial pressure, caused e.g., by severe traumatic brain injury or ischemic brain injury.
- •Subjects with significant respiratory depression, with acute or severe bronchial asthma or hypercapnia, and suspected or diagnosed sleep apnea.
- •Presence or suspicion of paralytic ileus.
研究者
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