Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms.
Study Overview
Brief Summary
The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold symptoms.
Detailed Description
Double-blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Double blind study
Eligibility Criteria
- Ages
- 2 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant within 48 hours of the onset of common cold symptoms: headache, sneezing, sore throat, nasal obstruction, cough, coryza and body pain;
- •Signed Consent of the patient;
- •Participant whose tutors have the capacity to understand and consent to the child's participation in the clinical study, manifested by signing TCLE
Exclusion Criteria
- •Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
- •Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
- •Patients with history of hypersensitivity to any of the formula compounds;
- •Participation in clinical trial in the year prior to this study;
- •Patients with vaccine reaction;
- •Patients who have uncontrolled asthma however, participants in use of pulmonary corticosteroids (alone or in combination with other products) will be allowed if they are in stable dose and diagnosed with controlled asthma;
- •Patients with gastroesophageal reflux, gastric or duodenal ulcer or other serious disease of the gastrointestinal tract;
- •Patients with diabetes mellitus type I and II;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Patients who were in use of drugs that can interfere with flu symptoms evaluation.
Arms & Interventions
Irlanda-1-Association
For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.
Intervention: Irlanda-1-Association (Drug)
Placebo
For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms.
Time Frame: 7 days
Secondary Outcomes
- Safety will be evaluated by the adverse events occurrences(7 days)