ColdPhase 3RESFRINNCT05118672
Phase 3 Clinical Trial to Evaluate Paracetamol /Fexofenadine /Phenylephrine in Flu and Cold Treatment
A Phase 3 study testing Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) in people with Cold and Flu Symptom, run by Eurofarma Laboratorios S.A. at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cold, Flu Symptom
- What is being tested?
- Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 567 participants
- Where
- 2 sitesBrazil
- Study dates
- 26 Mar 2025to 26 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Eurofarma Laboratórios S.A
São Paulo, São Paulo, 06696-000
Clinica de Alergia Martti Antila
Sorocaba, São Paulo
About this study
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
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).
Read the 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).
- Conditions
- Cold, Flu Symptom
- Being tested
- Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg), Placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)Drug
Also called EF175
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.
PlaceboDrug
Also called EF175 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) | Experimental | Group 1: paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg FDC (experimental drug). Receives: Drug: Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) |
| Placebo group | Placebo comparator | Group 2: Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 hours
Secondary outcomes (4)
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.
Measured: 11 days
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).
Measured: 3 hours (± 30 minutes), 26 (± 2) hours and 3 (± 1) days after administration
duration of the experimental drug treatment
Duration (in days) of study treatment
Measured: 7 days
use of rescue medication
Amount (in number of tablets) of rescue medication used.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start26 Mar 2025
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118672
- Sponsor's protocol ID
- EF175
- Acronym
- RESFRIN
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05118672
- Acronym / sponsor ID
- RESFRIN / EF175
- Conditions
- Cold, Flu Symptom
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) | Experimental | Drug: Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)Group 1: paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg FDC (experimental drug). |
| Placebo group | Placebo comparator | Drug: PlaceboGroup 2: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)Also: EF175Subjects 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. | Drug | Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) |
| PlaceboAlso: EF175 PlaceboSubjects 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. | Drug | Placebo group |
Primary outcome
Relief of cold and flu symptoms
Time frame: 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
4 secondary outcomes
overall efficacy of the experimental drug
Time frame: 11 days
efficacy of the experimental drug on the nasal congestion symptoms
Time frame: 3 hours (± 30 minutes), 26 (± 2) hours and 3 (± 1) days after administration
duration of the experimental drug treatment
Time frame: 7 days
use of rescue medication
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) in people with Cold and Flu Symptom, run by Eurofarma Laboratorios S.A. at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of cold and flu symptoms (time frame: 26 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.