Ensayo clínico de fase 3 para evaluar paracetamol/fexofenadina/fenilefrina en el tratamiento de la gripe y el resfriado (RESFRIN)
Un ensayo multicéntrico, aleatorizado, de grupos paralelos, doble ciego, comparativo de la superioridad de la combinación de dosis fija de paracetamol 500 mg/fexofenadina 60 mg/fenilefrina 20 mg versus placebo en el tratamiento sintomático de la gripe y el resfriado
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
São Paulo
-
Sorocaba, São Paulo, Brasil
- Clinica de Alergia Martti Antila
-
São Paulo, São Paulo, Brasil, 06696-000
- Eurofarma Laboratórios S.A
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
|
|
Comparador de placebos: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Relief of cold and flu symptoms
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
overall efficacy of the experimental drug
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 7 days
|
Duration (in days) of study treatment |
7 days
|
|
use of rescue medication
Periodo de tiempo: 7 days
|
Amount (in number of tablets) of rescue medication used. |
7 days
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Infecciones del Tracto Respiratorio
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades de las vías respiratorias
- Infecciones por Picornaviridae
- Resfriado comun
- Químicos orgánicos
- Preparaciones farmacéuticas
- Aniluros
- Amidas
- Compuestos anilina
- Amina
- Acetanilidas
- Alcoholes
- Amino alcoholes
- Etanolaminas
- Paracetamol
- Fenilefrina
- fexofenadina
- Drogas, investigación
Otros números de identificación del estudio
- EF175
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .