EUCTR2011-001202-99-DE进行中（未招募）1 期
A Phase IIb/III, Double-Blind, Placebo-Controlled, Randomized Study Investigating the Safety, Tolerability and Efficacy of Flupirtine as Adjunct to Opioids When Administered to Cancer Subjects Who Are Experiencing Pain With Neuropathic Features
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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. Presence of a solid neoplasm and between the ages of 18 and 65 years, inclusive
- •2. Able to understand written and verbal communication in the primary language of the country in which the study is being undertaken
- •3. Life expectancy a minimum of 3 months with Karnofsky score =50 at the Screening Visit (Day -7)
- •4. History of daily pain attributable to cancer and requiring treatment with strong opioids for at least 3 months duration
- •5. Pain with neuropathic characteristics that include one or more of the following: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting, tiring-exhausting, sickening, fearful, punishing-cruel, electric-shock, cold-freezing, piercing, caused by light touch, itching, tingling or ‘pins and needles’, or numbness.
- •6. Pain inadequately relieved despite active management including strong opioids
- •7. Currently taking morphine, oxycodone, hydromorphone, buprenorphine, or transdermal fentanyl for daily, non-breakthrough pain management (i.e., maintenance opioid treatment) with no changes in dose in the 2 weeks preceding the Screening Visit (Day -7)
- •8. Completion of a daily diary in which the 24-hour AP score has been entered for at least 5 of the last 7 days preceding Day 1
- •9. Average of non-missing 24-hour AP scores over the last 7 days before the day of randomization is 4 or greater
- •10. If on gabapentin, pregabalin or selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, no changes in dose in the 2 weeks preceding the Screening Visit (Day -7)
- •11. Willing to maintain existing analgesic medications, including maintenance opioid treatment, at same dose(s) and schedule for a minimum of 6 weeks following the Screening Visit (Day -7)
- •12. Able to take oral medication
- •13. If female subject of childbearing potential, a negative serum beta human chorionic gonadotropin (hCG) pregnancy test, performed at the Screening Visit (Day -7). Must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study and for 30 days following study drug exposure.
- •14. Willing and able to comply with protocol requirements for the duration of study participation
- •15. Contractual capability and signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Medical condition or illness other than solid neoplasm that would, in the opinion of the Investigator, preclude study participation or interfere with the assessment of pain
- •2. Abnormal liver or kidney function as defined by alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase in excess of 3 times the upper limit of normal, or chronic kidney disease worse than stage II (glomerular filtration rate <60 mL/min as calculated by Cockroft-Gault formula [(140-age) x (weight in kilograms) x (0.85 if female) / (72 x serum creatinine in mg/dl)])
- •3. Significant pain with neuropathic features which cannot be attributed to underlying malignancy
- •4. Proven hypersensitivity to flupirtine or one of the other ingredients
- •5. Cholestasis, pre-existing liver disease, or at risk of hepatic encephalopathy
- •6. Use of paracetamol-containing medications or carbamazepine
- •7. History of radiotherapy or a nerve block or other anesthetic procedure to the presumed site of nerve damage within 4 weeks preceding the Screening Visit (Day -7). Such procedures after the Screening Visit will necessitate withdrawal from the study.
- •8. If receiving a bisphosphonate medication, change in dose or frequency within 3 months preceding the Screening Visit (Day -7)
- •9. If receiving a hormonal contraceptive, change in dose or frequency within 3 months preceding the Screening Visit (Day -7)
- •10. Systemic radioisotope therapy within 1 month preceding the Screening Visit (Day-7)
- •11. Significant history of illicit drug or alcohol abuse
- •12. Current or previous (within 30 days of first study dosing) treatment with another investigational drug or participation in another clinical study
- •13. Change in chemotherapy regimen anticipated within 6 weeks following the Screening Visit
- •14. Pregnant or lactating females. Serum pregnancy test must be performed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start;
- •15. Known hepatitis B or C or HIV infection
- •16. Not suitable for study participation in the Investigator’s judgment
- •17. Previous participation in this study
- •18. Patient is a relative of, or staff directly reporting to the Investigator
- •19. Patient is an employee of the sponsor
- •20. Subject is committed under official or judicial order
- •21. Patient with a known diagnosis of myasthenia gravis
- •22. Patient with a known diagnosis of tinitus
- •23. Patients with metastatic liver disease (accompanied by change in LFTs to >2x ULN)
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