Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold

EMS

Status and phase

Withdrawn

Phase 3

Conditions

Common Cold

Treatments

Drug: Placebo

Drug: Irlanda-2-Association

Study type

Interventional

Funder types

Industry

Identifiers

EMS1115

Details and patient eligibility

About

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

Full description

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

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Exclusion criteria

Patients with any clinically significant disease that, in the investigator opinion, can´t participate in the study;
Patients with any laboratory finding or image finding that, in the investigator 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 in use of drugs that can interfere with flu symptoms evaluation.