Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children

Phase 3

Withdrawn

• Conditions: Common Cold
• Interventions: Drug: Placebo; Drug: Irlanda-1-Association

• Registration Number: NCT02656888
• Lead Sponsor: EMS

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 Timeline

• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Study Start: 2019-06
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-16
• Primary Completion: 2020-06
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Irlanda-1-Association	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.

Primary Outcome Measures

Name	Time	Method
Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms.	7 days

Secondary Outcome Measures

Name	Time	Method
Safety will be evaluated by the adverse events occurrences	7 days

Trial Locations

Locations (1)

Allergisa; 🇧🇷 Campinas, São Paulo, Brazil