ISRCTN17435333进行中（未招募）3 期
An adaptive-design randomised placebo-controlled trial of baclofen in the treatment of alcohol use disorder in patients with liver cirrhosis
niversity of Liverpool0 个研究点目标入组 400 人开始时间: 2023年10月13日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •at Registration:
- •1. Age 18 to 65 years
- •2. Confirmed diagnosis of alcohol-related cirrhosis classified according to the Child-Pugh classification
- •3. Abstinent from alcohol at the time of registration for between =1 day and <42 days
- •4. Capacity to provide informed consent
- •at Randomisation:
- •1. Age 18 to 65 years
- •2. Confirmed diagnosis of alcohol-related cirrhosis classified according to the Child-Pugh classification
- •3. Abstinent from alcohol at the time of the baseline/randomisation visit for between =14 days and <56 days
- •4. Capacity to provide informed consent
- •5. Women of reproductive potential must have a negative pregnancy test at randomisation and use highly effective contraception for the duration of the treatment period
排除标准
- •At registration:
- •1. Planning to become pregnant, is pregnant or breastfeeding
- •2. Overt hepatic encephalopathy or trans-jugular intrahepatic porto-systemic shunt in situ
- •3. Severe renal impairment (stage 5 chronic kidney disease and/or current haemodialysis)
- •4. History of illicit drug use excluding marijuana in the previous 4 weeks
- •5. Concurrent use of opioid substitution therapy
- •6. Use of licenced alcohol anti-craving pharmacotherapy (such as acamprosate, disulfiram naltrexone, nalmefene) in previous 12 weeks
- •7. Use of baclofen for any purpose in previous 12 weeks
- •8. Peptic ulceration detected by endoscopy within 14 days of registration.
- •9. Known hypersensitivity to baclofen or structurally related drugs or any other component of the formulation.
- •10. Poorly controlled major psychiatric disorder such as schizophrenia or bipolar disorder
- •11. Individuals who have participated in a trial of a medicinal product within 12 weeks preceding registration
- •12. Poorly controlled epilepsy
- •13. Rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption
- •14. Suffering from porphyria
- •At randomisation:
- •1. Planning to become pregnant, is pregnant or breastfeeding
- •2. Overt hepatic encephalopathy or trans-jugular intrahepatic porto-systemic shunt in situ
- •3. Severe renal impairment (stage 5 chronic kidney disease and/or current haemodialysis)
- •4. History of illicit drug use excluding marijuana in the previous 6 weeks
- •5. Concurrent use of opioid substitution therapy, or use in the previous 14 days
- •6. Use of licenced alcohol anti-craving pharmacotherapy (such as acamprosate, disulfiram naltrexone, nalmefene) in previous 14 weeks
- •7. Use of baclofen for any purpose in previous 14 weeks
- •8. Peptic ulceration detected by endoscopy within 28 days of the baseline/randomisation visit.
- •9. Known hypersensitivity to baclofen or structurally related drugs or any other component of the formulation
- •10. Scored 3 or more on the C-SSRS Screen and has been assessed by an appropriately qualified mental health practitioner as having suicidal ideation or behaviour prior to the baseline/randomisation visit
- •11. Poorly controlled major psychiatric disorder such as schizophrenia or bipolar disorder
- •12. Individuals who have participated in a trial of a medicinal product within 14 weeks preceding the baseline/ randomisation visit
- •13. Poorly controlled epilepsy
- •14. Rare hereditary problems of galactose intolerance, total lactose deficiency or glucosegalactose malabsorption
- •15. Suffering from porphyria
研究者
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