Clinical trial NCT05118672: Phase 3 Clinical Trial to Evaluate Paracetamol /Fexofenadine /Phenylephrine in Flu and Cold Treatment
Official title: A Multicenter, Randomized, Parallel-group, Double-blind, Comparative Trial of the Superiority of Paracetamol 500mg/Fexofenadine 60mg/Phenylephrine 20mg Fixed-dose Combination Versus Placebo in the Symptomatic Treatment of Flu and Cold
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cold
Flu Symptom
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2021-11-12
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.

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

Detailed 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).

Eligibility 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

Primary outcomes:
measure: Relief of cold and flu symptoms
timeFrame: 26 hours
Secondary outcomes:
measure: overall efficacy of the experimental drug
timeFrame: 11 days
measure: efficacy of the experimental drug on the nasal congestion symptoms
timeFrame: 3 hours (± 30 minutes), 26 (± 2) hours and 3 (± 1) days after administration
measure: duration of the experimental drug treatment
timeFrame: 7 days
measure: use of rescue medication
timeFrame: 7 days
Other outcomes:
Locations:
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila
state: SP
city: São Paulo
country: Brazil
facility: Eurofarma Laboratórios S.A
Study officials:
References: