| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Sleep disruption due to cough and nasal congestion during a cold. |
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| E.1.1.1 | Medical condition in easily understood language |
| Sleep disruption during a cold. |
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| E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10000938 |
| E.1.2 | Term | Acute nasopharyngitis (common cold) |
| E.1.2 | System Organ Class | 100000004862 |
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| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10009851 |
| E.1.2 | Term | Cold |
| E.1.2 | System Organ Class | 100000004862 |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
Efficacy Objective:
To investigate the efficacy of Vicks VapoRub versus placebo in reducing sleep disruption during a cold via its effect on cough and nasal congestion. |
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| E.2.2 | Secondary objectives of the trial |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
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 ΜΆ 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
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| E.4 | Principal exclusion criteria |
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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| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary Endpoint
sleep quality as measured by the SQSQ question “How was the quality of your sleep last night?”, where 0=Very good and 100=Very bad on a 100-mm VAS. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| All data for the primary endpoint will be averaged for all days in which the test product was taken. |
|
| E.5.2 | Secondary end point(s) |
• how refreshed did you feel upon waking as measured by the SQSQ;
• ease of falling asleep as measured by the VAS post-sleep questionnaire;
• depth of sleep as measured by the VAS post-sleep questionnaire;
• total sleep time as measured by Actiwatch and SQSQ;
• mean latency to persistent sleep as measured by the Actiwatch;
• mean sleep onset latency as measured by Actiwatch and SQSQ;
• mean activity score as measured by the Actiwatch;
• percentage of sleep as measured by the Actiwatch;
• sleep efficiency (ie, total sleep time / time in bed × 100) as measured by the Actiwatch and SQSQ;
• number of sleep bouts as measured by the Actiwatch;
• individual modified KSD questions (12 total);
• sleep quality index from modified KSD (derived mean from KSD questions 1, 2, 3, and 12). |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| All data for the secondary endpoints will be averaged for all days in which the test product was taken. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | Yes |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 5 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 5 |
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