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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT01721395
Eligibility Criteria:
Inclusion Criteria:
* Otherwise healthy male or female infant who is 2 to \<48 months of age.
* presents with a non-specific acute cough for 7 or fewer days' duration.
* Parents/legal authorized representative reporting at least moderate cough and cold symptoms.
* Parent/legal authorized representative was in the home with the child on the night prior to enrollment and plans to be in the home with the child on the night when study treatment will be administered
* Parent/legal authorized representative who is willing and able to comply with study requirements.
Exclusion Criteria:
* Previous participation in this clinical trial
* Gestational age at birth \<35 weeks.
* Signs or symptoms of a more treatable disease (eg, asthma, pneumonia, laryngotracheobronchitis, sinusitis, allergic rhinitis).
* Diagnosis of influenza, bronchiolitis or respiratory syncytial virus (RSV).
* History of reactive airways disease, asthma, or chronic lung disease.
* Use of any medication or honey to treat cough within 6 hours of bedtime on the evening prior to or on the day of enrollment.
* Presence of any significant disease including immunodeficiency, hepatic, renal,cardiovascular, or hematologic disease or any other health condition that, in the opinion of the investigator, would preclude participation in the study.
* Known allergy to agave nectar or grape flavoring
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
48 Months
Study:
NCT01721395
Study Brief:
Protocol Section:
NCT01721395