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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

567 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2025-08-26

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Cold Flu Symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Adult participants (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 500 mg / fexofenadine 60 mg / phenylephrine 20 mg) or placebo, in the dosage of one (01) film-coated tablet every eight (08) hours, for 3 to 7 days.

Randomized participants will be instructed to use the study treatment uninterruptedly, every eight (08) hours, for three (03) days, and may, after that, discontinue treatment at any time if they experience no more symptoms.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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

Group 2: Placebo.

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Subjects randomized to this group will receive one (01) experimental drug film-coated tablet every eight (08) hours for three (03) days (nine \[09\] dosage administration). Subjects will be instructed to, thereafter, maintain treatment at the same dosage (one \[01\] film-coated tablet every eight \[08\] hours) in case of persistence of symptoms, discontinuing treatment when they present with no symptoms.

Placebo group

Group 2: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects randomized to this group will receive one (01) experimental drug film-coated tablet every eight (08) hours for three (03) days (nine \[09\] dosage administration). Subjects will be instructed to, thereafter, maintain treatment at the same dosage (one \[01\] film-coated tablet every eight \[08\] hours) in case of persistence of symptoms, discontinuing treatment when they present with no symptoms.

Interventions

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

Subjects randomized to this group will receive one (01) experimental drug film-coated tablet every eight (08) hours for three (03) days (nine \[09\] dosage administration). Subjects will be instructed to, thereafter, maintain treatment at the same dosage (one \[01\] film-coated tablet every eight \[08\] hours) in case of persistence of symptoms, discontinuing treatment when they present with no symptoms.

Intervention Type DRUG

Placebo

Subjects randomized to this group will receive one (01) experimental drug film-coated tablet every eight (08) hours for three (03) days (nine \[09\] dosage administration). Subjects will be instructed to, thereafter, maintain treatment at the same dosage (one \[01\] film-coated tablet every eight \[08\] hours) in case of persistence of symptoms, discontinuing treatment when they present with no symptoms.

Intervention Type DRUG

Other Intervention Names

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EF175 EF175 Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No