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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05118672
Other study ID # EF175
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date November 30, 2024
Est. completion date December 30, 2025

Study information

Verified date May 2024
Source Eurofarma Laboratorios S.A.
Contact Gleyce Lima, Analyst
Phone 55 11 5090-8411
Email gleyce.lima@eurofarma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Not yet recruiting
Enrollment 478
Est. completion date December 30, 2025
Est. primary completion date October 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.
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.

Locations

Country Name City State
Brazil Eurofarma Laboratórios S.A São Paulo
Brazil Clinica de Alergia Martti Antila Sorocaba SP

Sponsors (1)

Lead Sponsor Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relief of cold and flu symptoms 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
26 hours
Secondary overall efficacy of the experimental drug subject's treatment overall evaluation 3 (±1) days after the administration of the first dose of study treatment from baseline. 11 days
Secondary efficacy of the experimental drug on the nasal congestion symptoms 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). 3 hours (± 30 minutes), 26 (± 2) hours and 3 (± 1) days after administration
Secondary duration of the experimental drug treatment Duration (in days) of study treatment 7 days
Secondary use of rescue medication Amount (in number of tablets) of rescue medication used. 7 days
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