EUCTR2007-002563-27-IT进行中（未招募）不适用
almefene Efficacy Study II: Randomised, double-blind, placebo-controlled, parallel-group, efficacy study of 20 mg nalmefene, as needed use, in patients with alcohol dependence - ND
适应症
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
- •The patient has alcohol dependence diagnosed according to DSM-IV-TR. The patient is a man or woman, aged 18 years or over.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The patient has less than 6 heavy drinking days (HDD) in the 4 weeks preceding the screening visit. A HDD is defined as a day with alcohol consumption of 60 g or more for males and 40 g or more for females 2. The patient has an average alcohol consumption below medium risk levels in the 4 weeks preceeding the screening visit (for males, ≤40 grams of ethanol/day, for females ≤20 grams of ethanol/day) 3. The patient has more than 14 consecutive abstinent days in the 4 weeks preceding the screening visit 4. The patient has a CIWA-Ar score of 10 or more 5. The patient has a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence evaluated by MINI, antisocial personality disorder evaluated by MINI, or other disorders for which the treatment takes priority over treatment of the drinking problem, or are likely to interfere with study treatment or impair treatment compliance Use of cannabis is not reason for exclusion unless fulfilling criteria for cannabis dependence. 6. The patient has risk of suicide evaluated by the suicidality module of MINI (the patient answers ?yes? to any of the questions C2, C3, C4, C5, or C6) 7. The patient has a history of delirium tremens or alcohol withdrawal seizures 8. The patient has a cognitive disorder as judged by the investigator 9. The patient reports or urine drug screen reveals current use of substances of abuse other than alcohol, cannabis, nicotine or benzodiazepines 10. The patient has seizure disorder, mental retardation, or encephalopathy 11. The patient has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance 12. The patient has clinically significant abnormal vital signs 13. The patient has S-ASAT and/or S-ALAT levels greater than 3 times of upper normal limit, or one or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant 14. The patient has a clinically significant abnormal ECG 15. The patient has a history of severe drug allergy or hypersensitivity 16. The patient reports current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate or naltrexone, topiramate, or with any opioid antagonists 17. The patient reports current or recent (within 1 week preceding screening) treatment with opioid agonists or partial agonists 18. The patient reports current or recent (within 8 weeks preceding screening) treatment with antipsychotics or antidepressants 19. The patient used/uses disallowed recent or concomitant medication (specified in Appendix II) or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study 20. The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy 21. The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to screening 22. The patient is currently participating or has recently (8 weeks prior to the screening visit) participated in a treatment or support programme for alcohol use disorders 23. The patient is pregnant or bre
研究者
相似试验
进行中（未招募）
不适用
almefene Efficacy Study II: Randomised, double-blind, placebo-controlled, parallel-group, efficacy study of 20 mg nalmefene, as needed use, in patients with alcohol dependenceAlcohol dependenceMedDRA version: 9.1Level: LLTClassification code 10001594Term: Alcohol dependence syndromeEUCTR2007-002563-27-CZH. Lundbeck A/S700
进行中（未招募）
不适用
almefene Efficacy Study II: Randomised, double-blind, placebo-controlled, parallel-group, efficacy study of 20 mg nalmefene, as needed use, in patients with alcohol dependenceMedDRA version: 9.1Level: LLTClassification code 10001594Term: Alcohol dependence syndromeAlcohol dependenceEUCTR2007-002563-27-PTH. Lundbeck A/S600
进行中（未招募）
不适用
almefene Efficacy Study II: Randomised, double-blind, placebo-controlled, parallel-group, efficacy study of 20 mg nalmefene, as needed use, in patients with alcohol dependenceAlcohol dependenceMedDRA version: 9.1Level: LLTClassification code 10001594Term: Alcohol dependence syndromeEUCTR2007-002563-27-BEH. Lundbeck A/S700
进行中（未招募）
1 期
almefene Efficacy Study II: Randomised, double-blind, placebo-controlled, parallel-group, efficacy study of 20 mg nalmefene, as needed use, in patients with alcohol dependenceAlcohol dependenceEUCTR2007-002563-27-FRH. Lundbeck A/S242
进行中（未招募）
不适用
almefene Efficacy Study II: Randomised, double-blind, placebo-controlled, parallel-group, efficacy study of 20 mg nalmefene, as needed use, in patients with alcohol dependenceMedDRA version: 13.1Level: LLTClassification code 10001594Term: Alcohol dependence syndromeSystem Organ Class: 10037175 - Psychiatric disordersAlcohol dependenceEUCTR2007-002563-27-PLH. Lundbeck A/S700