Phase 3 Clinical Trial to Evaluate Paracetamol /Fexofenadine /Phenylephrine in Flu and Cold Treatment
- Conditions
- ColdFlu Symptom
- Interventions
- Registration Number
- NCT05118672
- Lead Sponsor
- Eurofarma Laboratorios S.A.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 478
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo Group 2: Placebo Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) Group 1: paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg FDC (experimental drug).
- Primary Outcome Measures
Name Time Method Relief of cold and flu symptoms 26 hours absolute variation of the overall score obtained in the symptom assessment questionnaire (Likert Scale), in which nasal congestion, runny nose, sneezing, headache, myalgia, sore throat, throat pain hoarseness, cough and fever will be assessed on a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate and 3 = severe) after administration of the first dose of the study treatment from baseline.
The overall symptom score will be determined by the sum of the points assigned to the individual symptoms. The baseline overall score will vary in the interval of 6 to 30 points, ranging from 0 to 30 points in the other assessments, and the higher the score, the worse the subject's symptoms
- Secondary Outcome Measures
Name Time Method overall efficacy of the experimental drug 11 days subject's treatment overall evaluation 3 (±1) days after the administration of the first dose of study treatment from baseline.
efficacy of the experimental drug on the nasal congestion symptoms 3 hours (± 30 minutes), 26 (± 2) hours and 3 (± 1) days after administration Proportion of subjects with improved nasal congestion and runny nose 3 hours (± 30 minutes), 26 (± 2) hours and 3 (± 1) days after administration of the first dose of the study treatment from baseline, being considered improvement the reduction of at least one point on the 4-point categorical Likert scale (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
duration of the experimental drug treatment 7 days Duration (in days) of study treatment
use of rescue medication 7 days Amount (in number of tablets) of rescue medication used.
Trial Locations
- Locations (2)
Clinica de Alergia Martti Antila
🇧🇷Sorocaba, SP, Brazil
Eurofarma Laboratórios S.A
🇧🇷São Paulo, Brazil