Cold Clinical Trial
— RESFRINOfficial 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).
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Eurofarma Laboratórios S.A | São Paulo | |
Brazil | Clinica de Alergia Martti Antila | Sorocaba | SP |
Lead Sponsor | Collaborator |
---|---|
Eurofarma Laboratorios S.A. |
Brazil,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT02735070 -
Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold
|
Phase 3 | |
Completed |
NCT05247333 -
Implementation of a Minor Ailment Service in Community Pharmacy Practice
|
N/A | |
Recruiting |
NCT06158659 -
Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula
|
N/A | |
Active, not recruiting |
NCT05190432 -
Taxifolin/Ergothioneine and Immune Biomarkers in Healthy Volunteers (TaxEr)
|
N/A | |
Not yet recruiting |
NCT03089138 -
Efficacy and Safety of Regan Tangjiang for Treating the Common Cold With Wind-heat Syndrome
|
Phase 2 | |
Completed |
NCT00289237 -
Lifestyle Intervention in a General Population for Prevention of Ischaemic Heart Disease
|
N/A | |
Recruiting |
NCT05728918 -
Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People
|
N/A | |
Recruiting |
NCT02183779 -
PORH and Response to Cold in Raynaud's Phenomenon.
|
N/A | |
Completed |
NCT05920915 -
The Effect of the Cold Application on Venous Cannulation Pain
|
N/A | |
Recruiting |
NCT05454826 -
Investigation of the Effect of Cold Application in Migraine
|
N/A | |
Recruiting |
NCT04277494 -
The Acute Effect of Cold Spray Application on the Mechanical Properties of the Quadriceps Muscle in Athletes
|
N/A | |
Completed |
NCT01533220 -
Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal
|
Phase 3 | |
Not yet recruiting |
NCT04277481 -
The Acute Effect of Cold Pack Therapy Applied on Healthy People for Different Periods
|
||
Completed |
NCT03769012 -
Ability of Beta-glucan Supplementation to Augment Immune Function
|
N/A | |
Suspended |
NCT02904304 -
Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu
|
Phase 3 | |
Completed |
NCT02238210 -
Safety Trial of Atrovent® in Pediatric Patients With Rhinorrhea Associated With a Common Cold or Allergy
|
Phase 4 | |
Recruiting |
NCT05435144 -
Elderberry for Immune Support
|
N/A | |
Completed |
NCT02847663 -
The Effect of Whole Body Cryotherapy on Recovery and Performance: a Randomized Controlled Trial
|
N/A | |
Recruiting |
NCT02457533 -
Case Management - Active Telephone Support to Patients With COLD
|
N/A | |
Not yet recruiting |
NCT05317156 -
The Effect of Cold Vapor on Intubation-Related Symptoms and Comfort in the Early Postoperative Period
|
N/A |