EUCTR2013-004524-11-GB进行中（未招募）1 期
A 2-arm, randomised, single - (investigator) blind, controlled, parallel design study in common cold sufferers experiencing cough and nasal congestion to assess the effects of Vicks® VapoRub® (VVR) on elements of sleep quality - Sleep and VicksRub
Proctor and Gamble Technical Centres Ltd0 个研究点目标入组 100 人开始时间: 2013年12月3日最近更新:
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
- 入组人数
- 100
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
入选标准
- •1)be generally healthy by report and review of medication/medical history;
- •2)are at least 18 years of age and not older than 65 years of age;
- •3)have a body mass index (BMI) = 18.5 kg/m2 and = 30 kg/m2;
- •4)report that they are suffering from a self-diagnosed common cold of no more than 36 hours’ duration;
- •5)report that they are suffering from at least mild cough and nasal congestion due to the common cold (scores of at least 1 on the 4-point ordinal scale);
- •6)have an average score of < 50 on the 2 responses to the question How would you compare the quality of last night’s sleep with your usual sleep without a cold?” from the Leeds Sleep Evaluation Questionnaire (LSEQ), a 100-mm Visual Analog Scale (VAS), where Response 1 is 0 = Less restful than usual” and 100 = More restful than usual” and Response 2 is 0 = More periods of wakefulness than usual” and 100 = Fewer periods of wakefulness than usual”;
- •7)have a daily schedule that permits adequate time to sleep at night (between 7 ? 8.5 hours) and willing to go to bed at about the same time each evening;
- •8)be willing to refrain from taking medications known to effect sleep function (eg, antihistamines, nasal or oral cough/cold/allergy products, tranquilizers, sedatives, dietary supplements/herbal products, sleep-aids other than study medication, medications that contain stimulants, etc) during the study;
- •9)be willing to refrain from drinking alcohol during the study;
- •10)be willing to refrain from caffeinated beverages after 4:00 p.m.;
- •11)if female and of child-bearing potential, have practiced abstinence or used an effective form of birth control (eg, intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 3 months before being enrolled in the study; and
- •12)have read, understood, signed, and received a copy of the Informed Consent prior to initiation of the study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1)have previously diagnosed sleep disorders (egg, chronic insomnia, sleep apnea, restless legs syndrome, periodic limb movements);
- •2)have current sleep disturbances/poor sleep quality unrelated to their cold, based on the Pittsburg Sleep Quality Index (ie, a score of > 5 (Appendix 2);
- •3)have a clinically significant nasal abnormality (eg, deviated septum, ulcer, septal perforation, or polyp) discovered during the nasal examination at Screening;
- •4)have a history of clinically relevant anosmia;
- •5)have a history of allergy or hypersensitivity to the following ingredients: menthol, eucalyptus, turpentine, camphor, thymol, cedarwood, nutmeg;
- •6)have a history of significant airway disease or pronounced hypersensitivity of the airways/asthma or COPD, a significant history of recurrent sinusitis or currently experiencing allergic rhinitis, or significant history of chronic cough;
- •7)have a body temperature > 100.5°F (38.1°C);
- •8)used, within 5 half-lives, substances or medications known to affect sleep (including nicotine-replacement therapies, over-the-counter sleep aids, alcoholic beverages as sleep aid, or herbal products, the products) (If a substance or medication is known to affect sleep, but its half-life is not known, the substance/medication must not be used for 14 days prior to screening);
- •9)used nasal decongestants (including but not limited to phenylephrine, oxymetazoline, or pseudoephedrine) in the past 24 hours;
- •10)work at an occupation involving night or rotating shift work or need to travel across more than 2 time zones in the 14 days prior to screening or plan to do so during the study;
- •11)self-report typical consumption of more than 5 caffeinated beverages per day;
- •12)use nicotine in any form (eg, cigarettes, e-cigarettes, nicotine gum);
- •13)take naps daily;
- •14)used inhaled, topical, or oral nedocromil or cromolyn sodium, tricyclic antidepressant medications, or MAO inhibitors for 14 days prior to screening;
- •15)have a history of significant alcohol or drug abuse within the past 2 years;
- •16)are currently enrolled in another clinical trial, or have received any other investigational drug within the past 30 days;
- •17)have a positive urine pregnancy test at Screening or report they are pregnant, trying to become pregnant, or lactating, if female and of child-bearing potential;
- •18)have a history of a) malignancy within the past 2 years, other than treated basal cell carcinoma, or b) have current or past history of serious, severe, or unstable physical (eg, congestive heart failure, COPD, or other chronic breathing problems, such as asthma, emphysema, or chronic bronchitis, diabetes, thyroid disease) or psychiatric illness (eg, major depression, generalized anxiety disorder, claustrophobia); or
- •19)are taking a medication that the Investigator believes would interfere with the evaluation of the study, pose a safety risk, or confound the interpretation of the study results.
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