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

• Status: Suspended
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

National clinical trial, phase III, multicenter, randomized, prospective, double-blind, parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged equal or more than 18 years will be randomly allocated to one the drug group or placebo group.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ache Laboratorios Farmaceuticos S.A.
• Treatments: Desloratadine; Ibuprofen; Loratadine; Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

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

• Subjects diagnosed with common cold / flu syndrome defined by clinical evaluation and the presence of two or more of the following symptoms: sneezing, rhinorrhea, nasal obstruction, headache, throat discomfort, sore throat, dysphonia, myalgia, cough and fever 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 24 hours and a maximum of 72 hours prior to V0;

• Ability to understand and consent to participate in this clinical research, expressed by 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 [oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation]; other than surgically sterile (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-item J), unless the investigator considers that there may be a direct benefit to it;

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

• Any medical conditions which may interfere with efficacy and / or safety of the treatment with the investigational product, such as but not limited to disorders described 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