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

NCT ID: NCT02656888

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2020-09-30

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.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Irlanda-1-Association

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

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 Type: 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 Type: DRUG

Other Intervention Names

EMS association

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Allergisa

Campinas, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EMS0615

Identifier Type: -

Identifier Source: org_study_id