EUCTR2005-000922-22-GB进行中（未招募）不适用
A phase II double blind, randomised, placebo controlled, multicentre study to assess the efficacy and safety of TA-NIC in maintaining smoking cessation when given in conjunction with Nicotine Replacement Therapy (NRT) - Maintenance of smoking cessation in smokers who have quit (TA-NIC/03)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Xenova Ltd
- 入组人数
- 440
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. Age = 18 years
- •2. Male or female (females must be either of non child bearing potential, i.e., either surgically sterilised or post menopausal) or must be using adequate contraception, have a negative pregnancy test and must agree to continue to use this method of contraception until 3 months after the last immunisation. Acceptable contraceptive methods are oral or parenteral hormonal contraceptives; intrauterine device; barrier and spermicide. Abstinence or partner vasectomy are not acceptable methods.
- •3. A smoker” who has smoked on a regular basis for a least a year and is currently smoking at least 10 cigarettes per day
- •4. Motivated to quit
- •5. In good general health as determined by medical history, general clinical examination and laboratory tests and a WHO performance status of 0 or 1
- •6. Written informed consent
- •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. Known immunodeficiency
- •2. Patients taking medication known to have significant immunosuppression such as systemic glucocorticoid therapy (inhalers and topical formulations are permitted)
- •3. History of sensitivity to aluminium hydroxide gel
- •4. History of severe adverse reaction to cholera vaccine
- •5. Subjects taking medication that contains bupropion
- •6. History of substance abuse
- •7. Known allergy to components of NiQuitin CQ® patch
- •8. Non-cigarette tobacco use
- •9. Previous vaccination with TA-NIC
- •10. Participation in another clinical trial within thirty days prior to study entry
- •11. Women who are pregnant, lactating or who are planning to become pregnant.
- •12. Any subjects with a lab value outside the normal range, unless the value has been justified by the investigator in writing
- •13. Any other factor that in the opinion of the investigator would make the subject unsuitable for the trial e.g. alcohol abuse.
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