EUCTR2018-004229-10-PL进行中（未招募）1 期
DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF PHARMACODYNAMIC EFFECTS OF 4 MG NICOTINE GUM. A STUDY IN HEALTHY SMOKERS WILLING TO QUIT - Redbull Study - CCSSMC000766
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- McNeil AB
- 入组人数
- 220
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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Motivated and willing to quit smoking.
- •2. Healthy male or female subjects between the ages of 19 and 60 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as judged by the investigator based on a detailed medical history, physical examination, blood pressure and pulse rate measurements. The responsible investigator may request additional investigations or analyses to consider Nicorette Freshfruit label warnings and precautions if necessary.
- •3. Smoking more than 20 cigarettes per day regularly during at least one year prior to inclusion.
- •4. For females: Postmenopausal state (absence of menstrual discharge for at least one year and or premenopausal/perimenopausal state with an effective means of contraception (Section 9.3.4) during the study and 30 days thereafter.
- •5. For males: No pregnant spouse or partner at screening/baseline and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the study and 30 days thereafter.
- •6. A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
- •7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol, and able and willing to use an e-diary during the study period.
- •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 220
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Subjects presenting with any of the following will not be included in the study.
- •1. Hypersensitivity to the ingredients/components of the investigational products.
- •2. Current use of any contra-indicated medicine according to label for Nicorette Freshfruit.
- •3. Females: Pregnancy and/or breast-feeding.
- •4. History of alcoholism or substance abuse in the six months before screening/baseline, as judged by the Investigator.
- •5. Treatment with an investigational drug within 3 months preceding the first dose of study treatment.
- •6. Use of nicotine Chewing Gum the last 6 months.
- •7. Use of other therapies for smoking cessation the last 3 months, including, but not limited to NRT, varenicline, and cytisine.
- •8. Current use of e-cigarettes.
- •9. Preplanned surgery or procedures during the study period, if this may interfere with the conduct of the study.
- •10. Subjects ineligible to participate based on the warning and precautions” section of the label, based on the judgement of the Investigator.
- •11. Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson & Johnson (J&J) subsidiaries; and the families of each).
- •12. Member of the same household as another participant in the study.
- •13. Subjects working night shifts during the study period.
研究者
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