Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT00780403
Eligibility Criteria:
Inclusion Criteria:
* Subject and the parent/guardian of the subject, was to have demonstrated their willingness to participate in the study and comply with its procedures by signing a written Informed Consent
* 6-11 years old, either sex, either race
* If female, subject to be premenarcheal
* Willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior to enrollment.
* Free of any clinically significant disease that would interfere with study evaluations, including allergic rhinitis and respiratory infections.
* Able to adhere to the dosing and visit schedules
Exclusion Criteria:
* If female, subject who was pregnant, intended to become pregnant during the study or nursing.
* Subject had used any investigational product within 30 days prior to enrollment.
* Subject had any of the following clinical conditions: history of any significant medical conditions (based on reporting by parent or guardian): e.g., diabetes, heart disease, liver disease, kidney disease, breathing problems, cough with excessive phlegm, or persistent or chronic cough.
* Subject had a current medical condition that, in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, allergic rhinitis, etc.).
* Subject was participating in any other clinical study(ies).
* Subject was part of the staff or a family member of the staff personnel directly involved with this study.
* Subject was allergic to or has sensitivity to the study drug or its excipients.
* Subject had a history of allergic reaction to prescription and/or over the counter (OTC) medications and/or food products.
* Subject had used any antihistamines within 24 hours prior to tasting as outlined in Section 9.4.7.
* Subject used sedatives, tranquilizers, or monoamine oxidase inhibitor drugs.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
11 Years
Study:
NCT00780403
Study Brief:
Protocol Section:
NCT00780403