Nasal congestion due to common cold in adults
Conditions
Interventions
Trade Name: VicksVaporub
Product Name: Vicks Vaporub
Pharmaceutical Form: Ointment
Other descriptive name: LEVOMENTHOL
Concentration uni
Sponsors
Procter and Gamble
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) be generally healthy by report and review of medication/medical history; b) are at least 18 years of age; c) report that they are suffering from a self-diagnosed common cold of no more than 5 days’ duration; d) report that they are suffering from at least mild nasal congestion (score of at least 1 on the 4-point ordinal scale); e) are willing and able to refrain from eating, drinking, smoking, and putting anything into the mouth for a period of approximately 1 hour; f) are willing and able to stay alert and awake for a period of approximately 1 hour; g) 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 h) 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: a) have a clinically significant nasal abnormality (eg, deviated septum, ulcer, septal perforation, or polyp) discovered during the nasal examination at Screening; b) have history of clinically relevant anosmia; c) have a history of allergy or hypersensitivity to the following ingredients: menthol, eucalyptus, turpentine, camphor, thymol, cedarwood; d) have a history of airway disease or pronounced hypersensitivity of the airways/asthma; e) have an oral body temperature > 100.5°F (38.1°C); f) have used nasal decongestants (including but not limited to phenylephrine, oxymetazoline, or pseudoephedrine) in the past 24 hours; g) have used inhaled, topical, or oral nedocromil or cromolyn sodium, tricyclic antidepressant medications, or MAO inhibitors for 14 days prior to screening; h) have a history of alcohol or drug abuse within the past 2 years; i) are currently enrolled in another clinical trial, or have received any other investigational drug within the past 30 days; j) if female and of child-bearing potential, have a positive urine pregnancy test at screening or report they are pregnant, trying to become pregnant, or lactating; k) have a history of malignancy within the past 2 years, other than treated basal cell carcinoma; l) have a condition (eg, history of clinically significant pulmonary, autoimmune, psychiatric, neurologic, hematologic/oncologic, metabolic, endocrine, gastrointestinal, hepatic or renal disease) or are taking a medication, wearing devices, utilizing medicated skin ointments or creams and aromatic body creams or solutions that the Investigator believes would interfere with the evaluation of the study, pose a safety risk, or confound the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Stopclock labeled with the following instruction: “Stop the clock immediately when you feel any sensation of nasal cooling.” Subjects will continue the observation period until each clock has been stopped or 15 minutes have elapsed (observational window) indicating the end of the test period.;Main Objective: The objective of the study is to investigate the speed of action of Vicks Vaporub (VVR) and to provide data to design a pivotal study.;Secondary Objective: Not applicable.;Primary end point(s): Time to first experiencing sensation of nasal cooling | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to first experiencing sensation of nasal decongestion;Timepoint(s) of evaluation of this end point: The other stopclock will be labeled with a sign with the following instruction: “Stop the clock immediately when you feel any sensation of nasal decongestion.” Subjects will continue the observation period until each clock has been stopped or 15 minutes have elapsed (observational window) indicating the end of the test period. | — |
Countries
United Kingdom
Contacts
Public ContactDavid Hull (Principal Scientist)
Procter&Gamble Tech Centres
Outcome results
None listed