Evaluating a combination of medications for treating flu and cold symptoms
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
This study is testing a mix of medications to see if they can help adults with bad cold and flu symptoms feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 478 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eurofarma Laboratorios S.A. Industry-sponsored |
| Locations | 2 sites (Sorocaba, SP and 1 other locations) |
| Trial ID | NCT05118672 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial is a multicenter, randomized, double-blind, placebo-controlled study designed to assess the effectiveness of a combination of paracetamol, fexofenadine, and phenylephrine in alleviating symptoms of the flu and common cold. Adult participants aged 18 and older with moderate to severe symptoms will be randomly assigned to receive either the experimental drug or a placebo for a duration of 3 to 7 days. The primary outcome will be measured by the change in symptom severity scores from baseline to the end of treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older experiencing moderate to severe symptoms of the common cold or flu.
Not a fit: Patients with significant nasal obstruction, known hypersensitivity to the study medication, or requiring antibiotics for upper respiratory infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide effective relief from flu and cold symptoms for patients.
How similar studies have performed: Previous studies have shown promise in using similar combinations of medications for symptom relief, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sorocaba, SP and 1 other locations
- Clinica de Alergia Martti Antila — Sorocaba, Sp, Brazil (Recruiting)
- Eurofarma Laboratórios S.A — São Paulo, Brazil (Not_yet_recruiting)
Study contacts
- Study coordinator: Gleyce Lima, Analyst
- Email: gleyce.lima@eurofarma.com
- Phone: 55 11 5090-8411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.