Phase 3 Clinical Trial to Evaluate Paracetamol /Fexofenadine /Phenylephrine in Flu and Cold Treatment

• Status: Not yet recruiting
• Trial end date: 2025-03-30
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 3, multicenter, Randomized, Double-blind, comparative clinical trial to evaluate the association of paracetamol 500mg + Fexofenadine 60mg + Phenylephrine 20mg in the flu and common cold treatment

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

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Acetaminophen; Fexofenadine; Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

• Common cold: presence of moderate to severe nasal congestion AND moderate to severe runny nose AND at least one (01) of the following moderate to severe symptoms: sneezing, headache, myalgia, sore throat, throat pain, dysphonia, cough and fever.

Duration of symptoms ≤ 48 hours at screening. Informed Consent Form (ICF) signed before carrying out any study procedure.

Exclusion Criteria:

• Presence of significant septum deviation, compatible with impaired nasal ventilatory function, at the investigator's discretion.

• Presence of nasal polyposis to previous rhinoscopy.

• Known hypersensitivity to any component of the experimental drug formulation.

• Required antibiotic therapy for upper airway infection treatment