EUCTR2019-003502-28-CZ进行中（未招募）1 期
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of AP-325 in Subjects with Peripheral Post-surgical Neuropathic Pain
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 94
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
- •1. Subjects must be at least 18 years and not older than 80 years
- •2. Subjects with a diagnosis of chronic post-surgical neuropathic pain after breast surgery (breast cancer interventions), chest surgery (i.e. thoracotomy, video assisted thoracoscopy and sternotomy) or groin hernia repair (i.e. femoral hernia repairs and inguinal hernia repairs)
- •3. The chronic post-surgical pain developed or increased in intensity after the surgical procedure and persisted beyond the healing process, i.e. at least 3 months after the initiating event, as defined according to the international association for the study of pain (IASP) classification of chronic pain for ICD-11 (Schug et al., 2019)
- •4. Subjects must have ‘probable’ or ‘definite’ neuropathic pain as assessed by the revised IASP special interest group on neuropathic pain (NeuPSIG) grading system (Finnerup et al., 2016)
- •5. Subjects must be willing and able to discontinue and washout prohibited substances including
- •pain medications (e.g. antidepressants, anticonvulsants/antiepileptics, selective serotonin and dual reuptake inhibitors, opioids, long-acting benzodiazepines, muscle relaxants, and topical analgesics), except the rescue medication, and
- •substances known to be inhibitors or inducers of CYP2C9 and inhibitors of CYP3A4
- •for specific washout periods of at least 5 times the drug half-life
- •Note: Subjects using prohibited substances for other indications than neuropathic pain, e.g. antiepileptics for the treatment of epilepsy, may not be included in the study , because a discontinuation of such medication is not medically justifiable.
- •6. Permitted concomitant medications must have been stable for at least 4 weeks prior to Day -14 and any non-pharmacological therapies (e.g. physiotherapy, acupuncture and transcutaneous electrical neural stimulation) must have been initiated at least 3 weeks prior to Screening
- •7. Female subjects must not be pregnant or breastfeeding and be
- •of non-childbearing potential or
- •if of childbearing potential, use a highly effective contraceptive method from start of the IMP intake until 30 days after the last IMP intake and have a negative pregnancy test at Screening (blood test)
- •8. Male subjects must agree, from start of the IMP intake until 3 months after the last IMP intake, to refrain from donating sperm and use a male condom when having sexual intercourse with a woman of childbearing potential at any time and advise her to use a highly effective contraceptive method
- •9. Subjects must understand the nature of the study procedures and provide written informed consent prior to any study-related procedures
- •10. Body weight =55 kg for men and =50 kg for women
- •11. Body mass index (BMI) <35 kg/m²
- •Randomization criteria
- •1. At least 5 daily pain assessments in the baseline week prior to randomization, with a mean score on the PI-NRS =4 and =9. Differences between the baseline daily pain scores on the PI-NRS must be =50%.
- •2. For female subjects of childbearing potential: negative pregnancy test in urine on Day 1.
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Subjects with neuropathic pain not a result of a surgical procedure as defined in inclusion criterion 2
- •2. Subjects with any other coexisting pain that cannot be discriminated from post-surgical neuropathic pain, in the opinion of the subject or clinician
- •3. Subjects diagnosed with chronic post-surgical neuropathic pain with a disease duration exceeding 4 years
- •4. Inability to participate in the study, in the opinion of the investigator, because of, for example, severe brain damage, language barrier, dementia, or other clinically significant or unstable conditions
- •5. Subjects using adjuvant chemotherapy or radiotherapy; adjuvant therapies must have been finished at least weeks prior to the run-in period (Day - 14)
- •6. Creatinine clearance <60 mL/min using the Cockcroft-Gault formula
- •7. White blood cell count <2500/mm³; neutrophil count <1500/mm³; platelet count <100 x 10³/mm³
- •8. Heart rate <50 or >100 beats per minute; systolic blood pressure <100 or >140 mmHg; diastolic blood pressure <50 or >90 mmHg
- •9. A history of multiple drug allergies
- •10. History or presence of alcohol or drug abuse
- •11. Subjects using strong opioids (e.g. a Morphine Equivalent Dose
- •[MED] >80 mg/day)
- •12. Positive test for drugs of abuse at Day -7
- •13. Evidence of depression and/or a score of =11 on the HADS depression subscale
- •14. Psychiatric disease in the past 5 years
- •15. History of any liver disease within the last 6 months, or migraine, or
- •kidney dysfunction or disease (e.g. estimated glomerular filtration rate
- •[eGFR] =30 mL/min per 1.73 m²)
- •16. Clinically significant gastrointestinal conditions, likely interfering
- •with the study medication, study procedures or the outcome of the study
- •17. Positive test for human immunodeficiency virus (HIV)
- •18. Positive test for hepatitis B surface antigen (HBsAg), hepatitis B core
- •antibody (HBcAb), hepatitis C antibody and/or HIV1/HIV2 antibody at
- •19. Participation of subject in an interventional clinical study within 1
- •month or, if applicable, 5 half-lives of the IMP, whatever is longer,
- •before Screening or during participation in this study
- •20. Previous enrolment in this clinical study
- •21. Known hypersensitivity to the active substance or any of the
- •excipients of the IMP or the rescue medication
- •22. Subjects dependent (as an employee or relative) on the sponsor or
- •investigator
- •23. Subjects committed to an institution by virtue of an order issued
- •either by the judicial or the administrative authorities
- •24. Legal incapacity or limited legal capacity
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