Essai clinique de phase 3 pour évaluer le paracétamol/la fexofénadine/la phényléphrine dans le traitement de la grippe et du rhume (RESFRIN)
Essai comparatif multicentrique, randomisé, en groupes parallèles, en double aveugle sur la supériorité de l'association paracétamol 500 mg/fexofénadine 60 mg/phényléphrine 20 mg à dose fixe par rapport au placebo dans le traitement symptomatique de la grippe et du rhume
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).
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
São Paulo
-
Sorocaba, São Paulo, Brésil
- Clinica de Alergia Martti Antila
-
São Paulo, São Paulo, Brésil, 06696-000
- Eurofarma Laboratórios S.A
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
|
Comparateur placebo: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Relief of cold and flu symptoms
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
overall efficacy of the experimental drug
Délai: 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
Délai: 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
|
|
duration of the experimental drug treatment
Délai: 7 days
|
Duration (in days) of study treatment |
7 days
|
|
use of rescue medication
Délai: 7 days
|
Amount (in number of tablets) of rescue medication used. |
7 days
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections des voies respiratoires
- Infections
- Infections par virus à ARN
- Maladies virales
- Maladies des voies respiratoires
- Infections à Picornaviridae
- Rhume
- Produits chimiques organiques
- Préparations pharmaceutiques
- Anilides
- Amides
- Composés aniline
- Amines
- Acétanilides
- Alcools
- Alcools amino
- Éthanolamines
- Acétaminophène
- Phényléphrine
- fexofénadine
- Drogues, enquête
Autres numéros d'identification d'étude
- EF175
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .