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

Cold Clinical Trial

— RESFRIN  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05118672
• Other study ID #: EF175
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 30, 2024
• Est. completion date: March 30, 2026

Study information

• Verified date: October 2023
• Source: Eurofarma Laboratorios S.A.
• Contact: Edilene Macedo, Analyst
• Phone: 55 11 5090-8422
• Email: edilene.macedo[@]eurofarma.com
• Is FDA regulated: No
• 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: March 30, 2026
• Est. primary completion date: July 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

Related Conditions & MeSH terms

• Cold
• Flu Symptom

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