EUCTR2011-000575-14-IT进行中（未招募）不适用
Randomized, multicenter, double-blind, placebo-controlled study of the safety and efficacy of 4 dose regimens of SMO.IR, an oral solid formulation of sodium oxybate, in the maintenance of alcohol abstinence in recently abstinent alcohol-dependent patients
D&A PHARMA0 个研究点目标入组 495 人开始时间: 2012年4月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 495
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. Patients must already have signed and dated an informed consent form. 2. Male or female patients of any ethnic group, aged 18 years to 75 years inclusive and with BMI between 18.5 and 28 kg/m2 inclusive. 3. Patients must meet at least four criteria of alcohol dependence as defined by the DSM-IV-TR. 4. Patients must confirm at least 7 drinking days including at least 2 heavy drinking days in the last 14 days preceding screening. Alcohol drinking will be documented in TLFB calendar filled retrospectively by the patient at screening visit. 5. Patients who, in the judgment of the investigator, are motivated to completely abstain from alcohol. 6. Patients must have been abstinent for at least 3 days but up to 14 days with or without inpatient or outpatient detoxification prior to the randomization. The detoxification treatment (benzodiazepine agent, Alcover (Austria and Italy) or other) has to be washed out for at least 24 hours prior to the randomization. 7. Patients must be completely abstinent at the time of randomization and the Breath Alcohol Concentration test must be negative. 8. Patients who provided telephone number of the contact person who could be contacted in case of patient's unavailability. The presence of the contact person at the screening visit is not obligatory. 9. Patients agree to be contacted by the site during the study and provide valid phone contact to the investigator. 10. Laboratory parameters: ASAT and ALAT within 4 times upper limit of normal, and bilirubin level not greater or equal to 3.6 mg/dl. Other biochemical, urinalysis, and haematological tests except erythrocyte mean corpuscular volume (MCV) must be in the normal range or any deviation from the normal range must be rated as non clinically significant by the investigator. There is no limit for ?-GT. 11. Sexually active female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) at least 1 month before study entry and 1 month after the final treatment period. There is no need of contraception for male patients.
- •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 445
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Abstinence: more than 14 days prior to randomization. Patients treated with Alcover in the last 6 months. Treatment of withdrawal with Alcover at the time of study entry and/or during screening period is allowed. The wash-out period at least 24 hours between the last administration and randomization has to be kept. Patients who drunk between screening and randomization visit. Positive urine screen for cannabis, cocaine, heroin, amphetamines, benzodiazepine, barbiturates, methadone, ecstasy, tricyclic antidepressants, other opiates or any other substance of addiction detectable by urinalysis at randomization. Repeat urinalysis is allowed before the time limit for randomization: a repeat positive test is an exclusion criterion. In case of patients receiving benzodiazepine (BZD) agents during alcohol detoxification, a positive BZD urine test will be accepted at randomization and Week 1 visits but at no other visits, provided there is no evidence of BZD addiction. Current or recent history of a substance abuse or dependence on BDZ, amphetamines, cocaine, heroin, other opiates or any other substance except nicotine and caffeine as defined by the DSM-IV TR History of or current epileptic syndrome known medical history of succinic semialdehyde dehydrogenase deficiency. Concomitant psychotropic drugs including anti-epileptic and sedative antihistamine agents. Concomitant treatment with disulfiram, acamprosate, topiramate, baclofen or naltrexone. Conditions that require treatment with concomitant medications not allowed according to the study protocol. Patients with current psychiatric symptoms that meet axis 1 diagnostic criteria on DSM IV and require medication treatment. Patients with psychiatric disorder within the past 6 months that are not clinically stable and receiving or require any psychotropic medications. Patients with moderate to severe depression measured at the screening visit. Patients with moderate to severe anxiety measured at the screening visit. Patients with impaired hepatic and renal function 17. Any chronic GI disease or previous major abdominal surgery. Any significant cerebral vascular and/or cardiovascular disease. Chronic headaches and/or migraine, recurrent nausea and/or vomiting. Patients who have suffered any of the following within 1 year prior to the screening: mild/moderate traumatic brain injury, stroke, TIA, brain neoplasm. Severe traumatic brain injury within the last 15 years lasting or residual sequelae suggesting transient changes in consciousness. Any neurological or psychiatric disorders resulting in disorientation, memory impairment, inability to report accurately. Any clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments or may compromise the patient's safety during trial participation. History of malignancy within the past 2 years, with the exception of basal cell skin carcinoma and cervical cancer in situ with normal pap smear. Patient who, in the judgment of the investigator, is likely to be noncompliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development. Patients protected by law. Concurrent participation in another trial, or within 3 months of enrollment. Women who are pregnant or lactating.
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