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Un estudio para aprender sobre Zavegepant como tratamiento agudo de la migraña en adultos asiáticos

29 de abril de 2026 actualizado por: Pfizer

Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de Zavegepant intranasal (IN) para el tratamiento agudo de la migraña en adultos asiáticos

El propósito de este estudio es aprender qué tan seguro y efectivo se compara zavegepant con un placebo en el tratamiento agudo de la migraña en adultos asiáticos. La migraña es un dolor de cabeza muy doloroso con otros síntomas asociados como náuseas, fotofobia y fonofobia. Un placebo es un tratamiento inocuo que no tiene ningún efecto médico.

Este estudio busca participantes que:

  • tener al menos 1 año de antecedentes de migraña antes de ingresar al estudio.
  • tener de 2 a 8 ataques de migraña de intensidad moderada o severa en cada uno de los 3 meses antes de ingresar al estudio.
  • tener menos de 15 días con dolores de cabeza en cada uno de los 3 meses antes de ingresar al estudio. Los dolores de cabeza pueden deberse a la migraña o no.

Los participantes en este estudio recibirán zavegepant o placebo por vía intranasal. Intranasal significa medicamento que se administra por la nariz. Se tomará Zavegepant o placebo si los participantes tienen migraña de intensidad moderada o grave.

El estudio comparará las experiencias de las personas que reciben zavegepant con las de las personas que reciben un placebo. Esto ayudará a ver si zavegepant es seguro y efectivo en adultos asiáticos.

Los participantes estarán en este estudio durante un máximo de 16 semanas. Los participantes tendrán 3 visitas de estudio en la clínica del estudio y 1 a través de contacto telefónico.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

1414

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Corea del Sur
      • Seoul, Corea del Sur, 03181
        • Kangbuk Samsung Hospital
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Corea del Sur, 13620
        • Seoul National University Bundang Hospital
    • Kyǒnggi-do
      • Goyang-si, Kyǒnggi-do, Corea del Sur, 10380
        • Inje University - Ilsan Paik Hospital
      • Hwaseong-si, Kyǒnggi-do, Corea del Sur, 18450
        • Hallym University Dongtan Sacred Heart Hospital
      • Seongnam, Kyǒnggi-do, Corea del Sur, 13620
        • Seoul National University Bundang Hospital
      • Uijeongbu-si, Kyǒnggi-do, Corea del Sur, 11765
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
    • Pusan-kwangyǒkshi
      • Busan, Pusan-kwangyǒkshi, Corea del Sur, 49201
        • Dong-A University Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], Corea del Sur, 03080
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], Corea del Sur, 05505
        • Asan Medical Center
      • Seoul, Seoul-teukbyeolsi [seoul], Corea del Sur, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [seoul], Corea del Sur, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Seoul-teukbyeolsi [seoul], Corea del Sur, 07804
        • Ewha Womans University Seoul Hospital
  • Porcelana
      • Beijing, Porcelana, 100044
        • Peking University People's Hospital
      • Beijing, Porcelana, 100053
        • Xuanwu Hospital Capital Medical University
      • Chongqing, Porcelana, 404000
        • Chongqing University Three Gorges Hospital
      • Chongqing, Porcelana
        • The fourth people's hospital of chongqing
      • Shanghai, Porcelana, 200120
        • Shanghai East Hospital
      • Tianjin, Porcelana, 300000
        • Tianjin Union Medical Center
    • Anhui
      • Hefei, Anhui, Porcelana, 230011
        • The Second People's Hospital of Hefei
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100050
        • Beijing Friendship hospital, Capital Medical University
      • Beijing, Beijing Municipality, Porcelana, 100853
        • The First Medical Center of Chinese PLA General Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Porcelana, 400016
        • The First Affiliated Hospital of Chongqing Medical University
    • Hainan
      • Haikou, Hainan, Porcelana, 570311
        • Hainan General Hospital
    • Hebei
      • Wuhan, Hebei, Porcelana, 430060
        • Renmin Hospital of Wuhan University
    • Henan
      • Luoyang, Henan, Porcelana, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Luoyang, Henan, Porcelana, 471000
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Zhengzhou, Henan, Porcelana, 450000
        • People's Hospital of Zhengzhou
    • Hubei
      • Wuhan, Hubei, Porcelana, 430074
        • Wuhan Third Hospital
    • Hunan
      • Changsha, Hunan, Porcelana, 410013
        • The Third XIANGYA Hospital of Central South University
      • Changsha, Hunan, Porcelana, 410004
        • Changsha Central Hospital
    • Jiangsu
      • Lianyungang, Jiangsu, Porcelana, 222006
        • The Second People's Hospital of Lianyungang
      • Nanjing, Jiangsu, Porcelana, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Suzhou, Jiangsu, Porcelana, 215004
        • The Second Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, Porcelana, 214023
        • Wuxi People's Hospital
      • Wuxi, Jiangsu, Porcelana, 214125
        • Affiliated Hospital of Jiangnan University
      • Zhenjiang, Jiangsu, Porcelana, 212008
        • The Affiliated Hospital of Jiangsu University
    • Jiangxi
      • Pingxiang, Jiangxi, Porcelana, 337055
        • Pingxiang People's Hospital
    • Jilin
      • Changchun, Jilin, Porcelana, 130000
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, Porcelana, 110016
        • The People's Hospital of Liaoning Province
    • Ningxia
      • Yinchuan, Ningxia, Porcelana, 750001
        • The First People's Hospital of Yinchuan
      • Yinchuan, Ningxia, Porcelana, 750003
        • General Hospital of Ningxia Medical Hospital
    • Shaanxi
      • Xi'an, Shaanxi, Porcelana, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, Porcelana, 710068
        • Shaanxi Provincial People' Hospital
      • Xi'an, Shaanxi, Porcelana, 710075
        • Xian Gaoxin Hospital
      • Xianyang, Shaanxi, Porcelana, 716099
        • Xianyang Hospital of Yan'an University
    • Shandong
      • Jinan, Shandong, Porcelana, 250012
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, Porcelana, 250013
        • Jinan Central Hospital
      • Jining, Shandong, Porcelana, 272000
        • Affiliated Hospital of Jining Medical University
      • Liaocheng, Shandong, Porcelana, 252000
        • Liaocheng People's Hospital
      • Qingdao, Shandong, Porcelana, 266042
        • Qingdao Central Hospital
      • Rizhao, Shandong, Porcelana, 276800
        • People's Hospital of Rizhao
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200040
        • Huashan Hospital, Fudan University
      • Shanghai, Shanghai Municipality, Porcelana, 200123
        • Shanghai East Hospital
    • Shanxi
      • Changzhi, Shanxi, Porcelana, 046000
        • Heping Hospital Affiliated to Changzhi Medical College
    • Yunnan
      • Kunming, Yunnan, Porcelana, 650032
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310016
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
      • Rui’an, Zhejiang, Porcelana, 325200
        • Ruian People's Hospital
      • Wenzhou, Zhejiang, Porcelana, 325000
        • The First Affiliated Hosptial of Wenzhou Medical University
  • Taiwán
      • Taipei, Taiwán, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwán, 11490
        • Tri-Service General Hospital
      • Taoyuan, Taiwán, 333
        • Chang Gung Medical Foundation-Linkou Branch

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Participantes asiáticos de 18 años o más en la selección.

  • Participantes con un mínimo de 1 año de historia de migraña (con o sin aura) antes de la visita de selección, consistente con un diagnóstico de acuerdo con la Clasificación Internacional de Trastornos por Dolor de Cabeza, 3ra Edición, que incluye lo siguiente:

    1. Ataques de migraña presentes durante más de 1 año con una edad de inicio antes de los 50 años.
    2. Los ataques de migraña, en promedio, duran entre 4 y 72 horas si no se tratan.
    3. No más de 8 ataques de intensidad de dolor moderado o intenso por mes en los últimos 3 meses.
    4. Los participantes deben ser capaces de distinguir los ataques de migraña de las cefaleas tensionales/en racimos.
    5. Al menos 2 ataques de migraña consistentes de intensidad moderada o severa en cada uno de los 3 meses anteriores a la visita de selección y durante la fase de selección (autoinforme del participante).
    6. Menos de 15 días con dolores de cabeza (migrañosos o no migrañosos) por mes en cada uno de los 3 meses anteriores a la Visita de Selección y durante la Fase de Selección (autoinforme del participante).
    7. A los participantes que toman medicamentos profilácticos para la migraña se les permite continuar con la terapia si han recibido una dosis estable durante al menos 3 meses antes de la visita de selección y si no se espera que la dosis cambie durante la visita de finalización del tratamiento.
    8. Se pueden incluir participantes con contraindicaciones para el uso de triptanes siempre que cumplan con todos los demás criterios de ingreso al estudio.

Criterio de exclusión:

  • Antecedentes de migraña retiniana, migraña basilar o migraña hemipléjica.
  • Antecedentes o evidencia actual de enfermedad cardiovascular o cardiometabólica no controlada, inestable o recientemente diagnosticada.
  • Trastorno depresivo mayor, trastorno de ansiedad u otro trastorno psiquiátrico significativo.
  • Síndromes de dolor agudo o crónico, condiciones psiquiátricas, demencia o trastornos neurológicos significativos (distintos de la migraña) que interfieren con las evaluaciones del estudio.
  • Condiciones que pueden afectar la administración o absorción del producto nasal.
  • Dolores de cabeza por uso excesivo de medicamentos.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Droga: Placebo
Dosis única del placebo correspondiente tomada dentro de la fase de tratamiento.
Experimental: Zavegepant
Zavegepant intranasal 10 mg
Droga: Zavegepant
Los participantes recibirán una dosis activa única suficiente para tratar 1 dolor de cabeza por migraña de intensidad moderada o severa dentro de la Fase de Tratamiento.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Pain Freedom at 2 Hours Post-dose
Periodo de tiempo: At 2 hours post-dose
Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 2 hours post-dose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
Periodo de tiempo: At 2 hours post-dose
MBS was selected from nausea, phonophobia or photophobia before dosing by the participants. In this outcome measure, percentage of participants who recorded an MBS (present) before dosing and did not have the MBS (absent) at the time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Pain Relief at 15 Minutes Post-dose
Periodo de tiempo: At 15 minutes post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 15 minutes post-dose
Percentage of Participants With Pain Relief at 30 Minutes Post-dose
Periodo de tiempo: At 30 minutes post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 30 minutes post-dose
Percentage of Participants With Pain Relief at 2 Hours Post-dose
Periodo de tiempo: At 2 hours post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 2 hours post-dose
Percentage of Participants Who Returned to Normal Function at 2 Hours Post-dose
Periodo de tiempo: At 2 hours post-dose
Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
Periodo de tiempo: From 2 hours post-dose to 24 hours post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). This outcome of sustained pain relief was defined as pain intensity being mild or none at all time points from 2 to 24 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose.
From 2 hours post-dose to 24 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose
Periodo de tiempo: From 2 hours post-dose to 48 hours post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). This outcome of sustained pain relief was defined as pain intensity being mild or none at all time points from 2 to 48 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose.
From 2 hours post-dose to 48 hours post-dose
Percentage of Participants Who Returned to Normal Function at 30 Minutes Post-dose
Periodo de tiempo: At 30 minutes post-dose
Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 30 minutes post-dose) were reported.
At 30 minutes post-dose
Percentage of Participants Who Returned to Normal Function at 60 Minutes Post-dose
Periodo de tiempo: At 60 minutes post-dose
Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 60 minutes post-dose) were reported.
At 60 minutes post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
Periodo de tiempo: At 2 hours post-dose
Freedom from phonophobia was defined as phonophobia absent at specified time point for participants with the phonophobia present at the time of dosing. In this outcome measure, percentage of participants who had phonophobia at the time of dosing and then recorded phonophobia absent at the time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
Periodo de tiempo: At 2 hours post-dose
Freedom from photophobia was defined as photophobia absent at specified time point for participants with the photophobia present at the time of dosing. In this outcome measure, percentage of participants who had photophobia at the time of dosing and then recorded photophobia absent at the time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
Periodo de tiempo: At 2 hours post-dose
Freedom from nausea was defined as nausea absent at specified time point for participants with the nausea present at the time of dosing. In this outcome measure, percentage of participants who had nausea at the time of dosing and then recorded nausea absent at time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
Periodo de tiempo: From 2 hours post-dose to 24 hours post-dose
Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). Sustained pain freedom was defined as pain intensity being none at all time points from 2 to 24 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose.
From 2 hours post-dose to 24 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
Periodo de tiempo: From 2 hours post-dose to 48 hours post-dose
Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). Sustained pain freedom was defined as pain intensity being none at all time points from 2 to 48 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose.
From 2 hours post-dose to 48 hours post-dose
Percentage of Participants With Pain Relapse at Any Time Point After 2 Hours Post-dose to 48 Hours Post-dose
Periodo de tiempo: From after 2 hours post-dose to 48 hours post-dose
Pain relapse was defined as pain intensity of mild, moderate, or severe at any time point after 2 hours to 48 hours post-dose for participants with pain intensity of none at 2 hours post-dose. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
From after 2 hours post-dose to 48 hours post-dose
Percentage of Participants Taking Rescue Medication Within 24 Hours Post-dose
Periodo de tiempo: Within 24 hours post-dose
Participants who did not experience relief (pain intensity of none or mild) of their migraine headache at the end of 2 hours post-dose, or the migraine was relieved at 2 hours post-dose, but then recurred to a moderate or severe pain intensity level, were permitted to use the following rescue medications: aspirin, ibuprofen, naproxen (or any other type of nonsteroidal anti-inflammatory drug), acetaminophen up to 1000 mg/day (this included Excedrin Migraine), antiemetics (for example, metoclopramide or promethazine), or baclofen.
Within 24 hours post-dose
Percentage of Participants With Pain Relief at 60 Minutes Post-dose
Periodo de tiempo: At 60 minutes post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 60 minutes post-dose
Percentage of Participants Who Returned to Normal Function at 15 Minutes Post-dose
Periodo de tiempo: At 15 minutes post-dose
Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 15 minutes post-dose) were reported.
At 15 minutes post-dose
Number of Participants With Adverse Events (AEs) of Moderate or Severe Intensity: On-Treatment Period
Periodo de tiempo: On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Moderate AE: A type of AE that was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activity/activities of daily living (ADL), causing discomfort, but posed no significant or permanent risk of harm to the research participant. Severe AE: A type of AE that interrupted usual ADL, or significantly affected clinical status, or might have required intensive therapeutic intervention.
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Number of Participants With AEs of Moderate or Severe Intensity: Follow-up Period
Periodo de tiempo: Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Moderate AE: A type of AE that was usually alleviated with additional specific therapeutic intervention. The event interfered with usual ADL, causing discomfort, but posed no significant or permanent risk of harm to the research participant. Severe AE: A type of AE that interrupted usual ADL, or significantly affected clinical status, or might have required intensive therapeutic intervention.
Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
Number of Participants With Serious Adverse Events (SAEs): On-Treatment Period
Periodo de tiempo: On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic, or other situations.
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Number of Participants With SAEs: Follow-up Period
Periodo de tiempo: Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic, or other situations.
Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
Number of Participants With Local Irritation AEs: On-Treatment Period
Periodo de tiempo: On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local irritation AEs were associated with intranasal administration of study intervention (e.g., dysgeusia, nasal discomfort, oropharyngeal pain, throat irritation, and laryngeal discomfort).
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Number of Participants With Local Irritation AEs: Follow-up Period
Periodo de tiempo: Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local irritation AEs were associated with intranasal administration of study intervention (e.g., dysgeusia, nasal discomfort, oropharyngeal pain, throat irritation, and laryngeal discomfort).
Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
Number of Participants With Grade 3 to 4 Hematological Test Abnormalities: On-Treatment Period
Periodo de tiempo: On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Hematological test abnormalities included: anemia, eosinophilia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophils count decreased, platelet count decreased and white blood cell decreased. Only those hematology test categories in which at least one participant in at least one reporting arm experienced a Grade 3 or Grade 4 abnormality were reported in this outcome measure. The hematological test abnormalities grade 3 to 4 were graded according to the common terminology criteria for adverse events (CTCAE) version (v) 5.0.
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Number of Participants With Grade 3 to 4 Clinical Chemistry Test Abnormalities: On-Treatment Period
Periodo de tiempo: On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Clinical chemistry test abnormalities included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, blood lactate dehydrogenase increased, creatine phosphokinase (CPK) increased, chronic kidney disease, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia and hyponatremia. Only those clinical chemistry test categories in which at least one participant in at least one reporting arm experienced a Grade 3 or Grade 4 abnormality were reported in this outcome measure. The clinical chemistry test abnormalities grade 3 to 4 were graded according to the CTCAE v 5.0.
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pfizer

Investigadores

  • Director de estudio: Pfizer CT.gov Call Center, Pfizer

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

29 de noviembre de 2023

Finalización primaria (Actual)

30 de mayo de 2025

Finalización del estudio (Actual)

30 de mayo de 2025

Fechas de registro del estudio

Enviado por primera vez

3 de agosto de 2023

Primero enviado que cumplió con los criterios de control de calidad

3 de agosto de 2023

Publicado por primera vez (Actual)

14 de agosto de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • C5301008
  • NCT05989048 (Identificador de registro: ClinicalTrials.gov)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Pfizer brindará acceso a los datos individuales de los participantes anonimizados y a los documentos del estudio relacionados (p. protocolo, Plan de Análisis Estadístico (SAP), Informe de Estudio Clínico (CSR)) a solicitud de investigadores calificados, y sujeto a ciertos criterios, condiciones y excepciones. Se pueden encontrar más detalles sobre los criterios de intercambio de datos de Pfizer y el proceso para solicitar acceso en: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

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. .

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