Prospective Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients Undergoing a Methadone Maintenance Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 515
- 试验地点
- 20
- 主要终点
- Primary endpoint
研究概览
简要总结
The efficacy and tolerability of Eptadone® in the context of a maintenance program will be evaluated in an observational prospective, multicenter study, in heroin addicted patients.
详细描述
515 patients have been selected among all patients addicted to heroin according ICD-10, in maintenance treatment with Eptadone, observed in the involved sites. The investigators have used the treatment schemes with Eptadone conform to the registered use.
The enrollment has been competitive. Patients met incl/excl and that have signed the informed consent have been observed for 1 year. Follow up visits have been performed according to routine procedures, for patients related to the centres at 3/6/12 months post V1. During the visits patients have been assessed by validated and used as clinical practice questionaries. Safety and tolerability have been assessed through the collection of adverse reactions and of laboratory tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes
- •Over 18 years of age
- •Patients with a diagnosis of heroin addiction, according to ICD-10 (International Classification of Diseases-10)
- •Patients who receive a "maintenance treatment" with Eptadone® since at least one month
- •Accession to the observational study by informed consent
排除标准
- •Inability to follow the observation and to understand study procedure and follow them
- •Diagnosis of:
- •Decompensated psychotic disorders,
- •Epileptic attacks, not related with drug abuse,
- •Severe-acute or severe-chronic somatic diseases (like AIDS, Tubercolosis, acute hepatitis, Sepsis ecc), whereas chronical HCV is not an exclusion criteria.
结局指标
主要结局
Primary endpoint
时间窗: From baseline to end of study (12 months after baseline)
Efficacy and Tolerability of maintenance treatment with Eptadone®, in patients addicted to heroin.
次要结局
- Secondary endpoints(From baseline to end of study (12 months after baseline))