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

Eurofarma

Status and phase: Completed; Phase 3

Conditions: Flu Symptom; Cold

Treatments: Drug: Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05118672

EF175

Details and patient eligibility

About

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.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Full description

A multicenter, randomized, double-blind, parallel-group, superiority, placebo control clinical trial.

Adult patients (aged ≥ 18 years) of both sexes with common cold or flu will be randomized in a 1:1 ratio to receive the experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) or placebo, in the dosage of one (01) film-coated tablet every eight (08) hours, for 3 to 7 days.

The primary superiority assessment will be carry out compared the experimental drug to placebo in the relief of cold and flu symptoms through the absolute variation of the overall score obtained in the symptom assessment questionnaire after treatment start.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Enrollment: 567 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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567 participants in 2 patient groups, including a placebo group

Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)

Experimental group

Description:

Group 1: paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg FDC (experimental drug).

Treatment:

Drug: Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)

Placebo group

Placebo Comparator group

Description:

Group 2: Placebo

Treatment:

Drug: Placebo