EUCTR2006-005334-21-DE进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, parallel group, fixed-dose, 8-weektreatment, multi-center trial evaluating the dose effect relationship for efficacy and the safety of 3 oral doses of surinabant: 2.5, 5 and 10mg/day as an aid to smoking cessation in cigarette smokers - SURSMOKE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 805
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
- •Patients over legal age, smoking at least 10 cigarettes/day as a mean within the 6 months preceding the screening visit.
- •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
- •Related to study methodology
- •1. Level of motivation to quit less than 6 on a ten-point Likert Scale.
- •2. Refusal or inability to give informed consent to participate in the study.
- •3. Not able to follow verbal and written instructions and to complete all aspects of the study.
- •4. Other participant in a household enrolled in the study.
- •5. Patients who have a history of multiple allergic reactions to medications in two drug classes.
- •6. Patients who have taken an investigational drug within the past 6 months prior to the screening visit.
- •7. Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product (other than cigarettes such as cigars, pipes, smokeless tobacco, etc) more than 3 days within the 3 months preceding the screening visit.
- •8. Patients dependent to alcohol or illicit drugs.
- •9. Patients who have smoked or consumed marijuana in any form on more than one
- •occasion during the past 3 months.
- •10. Presence of any clinically significant current acute or chronic unstable neurological, gastrointestinal, cardiovascular, renal, hematological, endocrine, dermatological or respiratory disease, or any other medical condition including that might interfere with the evaluation of study medication.
- •11. Patients with a lifetime diagnosis (based on DSM-IV) of Psychotic Disorder.
- •12. Patients who currently present with (based on DSM-IV) a Major Depressive Episode (unstable and/or treated efficiently by an antidepressant since less than 6 months).
- •13. Patients who have suffered from a myocardial infarction, unstable angina or other
- •major cardiovascular event within the past 6 months prior to screening.
- •14. Subjects who have an ECG abnormality, detected at screening and confirmed by repeated test, which is clinically significant according to the investigator, including a QT interval > 470 msec or a QTcF (with Fridericia's correction) > 470 msec and subjects with risk factors for Torsade de Pointes (cardiac insufficiency with grades II-IV according to the New York Heart Association classification (see Appendix D), hypokaliemia at randomization or family history of long QT-syndrome).
- •15. Pregnant or breast-feeding women.
- •16. Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. Medically acceptable methods of birth control for this study include approved hormonal contraceptive medications or devices, approved intra-uterine contraceptive devices, use of two combined barrier methods.
- •Related to surinabant
- •17. Treatment with CYP3A4 potent inhibitors, see list given in Appendix A of the protocol. If previously administered, the patient should have stopped taking these drugs at least 4 weeks prior to randomization. Patients receiving other inhibitors of CYP3A4 can be included but therapeutic substitution should be considered whenever possible.
研究者
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