Fase 3 klinische studie ter evaluatie van paracetamol/fexofenadine/fenylefrine bij de behandeling van griep en verkoudheid (RESFRIN)
Een multicenter, gerandomiseerde, parallelgroep, dubbelblinde, vergelijkende studie van de superioriteit van paracetamol 500 mg/fexofenadine 60 mg/fenylefrine 20 mg vaste-dosiscombinatie versus placebo bij de symptomatische behandeling van griep en verkoudheid
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).
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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São Paulo
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Sorocaba, São Paulo, Brazilië
- Clinica de Alergia Martti Antila
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São Paulo, São Paulo, Brazilië, 06696-000
- Eurofarma Laboratórios S.A
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)
Group 1: paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg FDC (experimental drug). |
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.
Andere namen:
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Placebo-vergelijker: Placebo group
Group 2: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Relief of cold and flu symptoms
Tijdsspanne: 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 |
26 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
overall efficacy of the experimental drug
Tijdsspanne: 11 days
|
subject's treatment overall evaluation 3 (±1) days after the administration of the first dose of study treatment from baseline. |
11 days
|
|
efficacy of the experimental drug on the nasal congestion symptoms
Tijdsspanne: 3 hours (± 30 minutes), 26 (± 2) hours and 3 (± 1) days after administration
|
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
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duration of the experimental drug treatment
Tijdsspanne: 7 days
|
Duration (in days) of study treatment |
7 days
|
|
use of rescue medication
Tijdsspanne: 7 days
|
Amount (in number of tablets) of rescue medication used. |
7 days
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Luchtweginfecties
- Infecties
- RNA-virusinfecties
- Virusziekten
- Ziekten van de luchtwegen
- Picornaviridae-infecties
- Verkoudheid
- Organische chemicaliën
- Farmaceutische voorbereidingen
- Anilides
- Amides
- Aniline -verbindingen
- Amines
- Acetaniliden
- Alcohol
- Aminoalcoholen
- Ethanolamines
- Paracetamol
- Fenylefrine
- Fexofenadine
- Drugs, onderzoek
Andere studie-ID-nummers
- EF175
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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