EUCTR2007-003250-29-DK进行中（未招募）不适用
A randomised, placebo-controlled, multi-centre study on the efficacy of Niccine, a vaccine for nicotine, in smoking relapse prevention, assessed in abstinent, adult smokers.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
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.Cigarette smokers, smoking on average at least 10 cigarettes per day, has fewer than three months of abstinence in the past year and is motivated to quit.
- •2.Men or women, 25 to 50 years of age (inclusive).
- •3.Women of childbearing capacity must use a reliable contraceptive method, e.g. the double barrier method, an intra-uterine device or oral contraceptive.
- •4.Positive for exhaled carbon monoxide (CO), >5 ppm.
- •5.Healthy and with normal findings in the pre-study physical examination (as judged by the Investigator)
- •6.Has signed the Informed Consent Form
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Pregnant and lactating female
- •2.Previous treatment with any nicotine vaccine
- •3.Vaccination with any other vaccine product from four weeks before first dose or planned vaccination until four weeks after the last vaccination with the investigational product.
- •4.Vaccination with any other medicinal product containing TT within two years prior to enrolment.
- •5.Concurrent use of any drug that may have a negative effect on the immune system (as judged by the investigator)
- •6.Use of antidepressant or antipsychotic drugs within six months prior to enrolment in the study
- •7.Concurrent use of any other nicotine containing product than cigarettes
- •8.Current diagnosis or a history of repeated depressive episodes or of anxiety disorders or psychosis.
- •9.Clinical diagnosis of moderate to severe asthma or COPD or emphysema.
- •10.Unstable heart disease (as judged by the Investigator).
- •11.Use of any smoking cessation drugs within six months of enrolment in the study.
- •12.Known hyper reactivity to previous vaccinations with TT.
- •13.Known or suspected allergy or hypersensitivity to any of the components in the investigational or reference products.
- •14.Suspected abuse or misuse of alcohol or any of the drugs tested for during screening.
- •15.Diseases with immunological etiology, e.g. autoimmune disorders.
- •16.History of cancer.
- •17.Positive serology for HIV and/or Hepatitis B and/or Hepatitis C.
- •18.Participation in another clinical study within three months prior to enrolment or during the present study.
- •19.If the Investigator, for any other reason, assesses that the Subject should not be included (e.g. planned travel, expected low compliance, expected withdrawal).
研究者
相似试验
进行中（未招募）
不适用
A randomised, placebo-controlled, multi-centre study on the efficacy of Niccine, a vaccine for nicotine, in smoking relapse prevention, assessed in abstinent, adult smokers.EUCTR2007-003250-29-SEIndependent Pharmaceutica AB360
进行中（未招募）
1 期
A multicentre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GW642444H (100 and 400mcg administered once-daily in the morning via DISKUS™ dry-powder inhaler) compared with salmeterol (50mcg administered twice-daily via DISKUS dry-powder inhaler) and placebo in subjects with moderate COPD.Chronic Obstructive Pulmonary DiseaseEUCTR2006-004033-15-NLGlaxoSmithKline Research and Development Limited
进行中（未招募）
1 期
A study of SBC-102 (enzyme replacement therapy) in patients with lysosomal acid lipase deficiencyysosomal Acid Lipase DeficiencyMedDRA version: 20.0Level: HLTClassification code 10024579Term: Lysosomal storage disordersSystem Organ Class: 100000004850EUCTR2011-002750-31-PLAlexion Pharmaceuticals, Inc.66
进行中（未招募）
1 期
A study of SBC-102 (enzyme replacement therapy) in patients with lysosomal acid lipase deficiencyEUCTR2011-002750-31-CZAlexion Pharmaceuticals, Inc.66
进行中（未招募）
1 期
A study of SBC-102 (enzyme replacement therapy) in patients with lysosomal acid lipase deficiencyysosomal Acid Lipase DeficiencyMedDRA version: 14.1Level: HLTClassification code 10024579Term: Lysosomal storage disordersSystem Organ Class: 100000004850EUCTR2011-002750-31-ITSynageva BioPharma Corporation66