Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu

Inclusion Criteria:

• Age older or equal to 18 and younger than 66 years;

• Subjects diagnosed with common cold / flu syndrome defined by clinical evaluation andthe presence of two or more of the following symptoms: sneezing, rhinorrhea, nasalobstruction, headache, throat discomfort, sore throat, dysphonia, myalgia, cough andfever classified as moderate or intense in four intensity scale (04) items (0 =absent, 01 = light, 02 = moderate, 03 = severe);

• Beginning of the symptoms of common cold / flu-like syndrome in a minimum period of 24hours and a maximum of 72 hours prior to V0;

• Ability to understand and consent to participate in this clinical research, expressedby signing the Informed Consent Form (ICF);

Exclusion Criteria:

• Any laboratorial finding (clinical evaluation / physical evaluation / vital signs /ECG changes) that the Investigator consider a risk to subject of the study;

• Hypersensitivity to the drug components used during the study;

• Women in pregnancy or nursing period;

• Women in reproductive age who do not agree to use contraception acceptable [oralcontraceptives, injectable contraceptives, intrauterine device (IUD), hormonalimplants, barrier methods, hormonal patch and tubal ligation]; other than surgicallysterile (bilateral oophorectomy or hysterectomy), postmenopausal for at least one (01)years or sexual abstinence;

• Subjects that has participated in clinical trial protocols in the last twelve (12)months (National Board of Health- Resolution 251 of 07 August 1997, Part III, sub-itemJ), unless the investigator considers that there may be a direct benefit to it;

• Alcohol abuse that, according to the investigator, may interfere with thepharmacological adherence to the clinical protocol;

• Any medical conditions which may interfere with efficacy and / or safety of thetreatment with the investigational product, such as but not limited to disordersdescribed below:

• Untreated or uncontrolled Hyperthyroidism

• Uncontrolled epilepsy

• diagnosis of glaucoma

• Moderate or severe persistent asthma (untreated or uncontrolled)

• NSAID-induced asthma diagnosed

• Systemic hypertension (SH) stage III uncontrolled

• Moderate and severe congestive heart failure

• Acute myocardial infarction

• unstable angina

• Uncontrolled cardiac arrhythmia

• Liver failure with clinical consequences

• Renal failure with clinical consequences

• Diagnosed HIV positive

• uncontrolled Diabetes type 1 or type 2