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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Common Cold
• Intervention / Treatment: Drug: Irlanda-1-Association; Drug: Placebo

Detailed Description

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

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Campinas, São Paulo, Brazil
      • Allergisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: EMS association
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms.	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety will be evaluated by the adverse events occurrences	7 days

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: EMS0615

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No