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

NCT02656888 | Withdrawn Phase 3 DMC

• 1 other identifier: EMS0615
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms.

  7 days

Secondary Outcomes (1)

• Safety will be evaluated by the adverse events occurrences

  7 days

Study Arms (2)

Irlanda-1-Association

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Irlanda-1-Association DRUG

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.

Also known as: EMS association

Irlanda-1-Association

Placebo DRUG

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

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

Allergisa

Campinas, São Paulo, Brazil

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 15, 2016
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

BR (1)