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

Common Cold Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02656888
• Other study ID #: EMS0615
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 2019
• Est. completion date: September 2020

Study information

• Verified date: October 2019
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold symptoms.

Description:

Double-blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Common Cold

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Allergisa	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms.		7 days
Secondary	Safety will be evaluated by the adverse events occurrences		7 days