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Une étude pour en savoir plus sur Zavegepant comme traitement aigu de la migraine chez les adultes asiatiques

29 avril 2026 mis à jour par: Pfizer

Une étude de phase 3, randomisée, en double aveugle, contrôlée par placebo et en groupes parallèles pour évaluer l'efficacité et l'innocuité de Zavegepant intranasal (IN) pour le traitement aigu de la migraine chez les adultes asiatiques

Le but de cette étude est d'apprendre comment le zavegepant est sûr et efficace par rapport au placebo dans le traitement aigu de la migraine chez les adultes asiatiques. La migraine est un mal de tête très douloureux avec d'autres symptômes associés tels que nausées, photophobie et phonophobie. Un placebo est un traitement inoffensif qui n'a aucun effet médical.

Cette étude recherche des participants qui :

  • avoir au moins 1 an d'antécédents de migraine avant d'entrer dans l'étude.
  • avoir 2 à 8 crises de migraine d'intensité modérée ou sévère au cours de chacun des 3 mois précédant l'entrée dans l'étude.
  • avoir moins de 15 jours avec des maux de tête dans chacun des 3 mois avant d'entrer dans l'étude. Les maux de tête peuvent être dus à la migraine ou non.

Les participants à cette étude recevront du zavegepant ou un placebo par voie intranasale. Par voie intranasale, on entend un médicament administré par le nez. Zavegepant ou un placebo seront pris si les participants ont une migraine d'intensité modérée ou sévère.

L'étude comparera les expériences des personnes recevant du zavegepant à celles des personnes recevant un placebo. Cela aidera à voir si zavegepant est sûr et efficace chez les adultes asiatiques.

Les participants seront dans cette étude jusqu'à environ 16 semaines. Les participants auront 3 visites d'étude à la clinique d'étude et 1 par contact téléphonique.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

1414

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Critère d'intégration:

  • Participants asiatiques âgés de 18 ans ou plus au moment du dépistage.

  • Participants ayant au moins 1 an d'antécédents de migraine (avec ou sans aura) avant la visite de dépistage, compatibles avec un diagnostic selon la Classification internationale des maux de tête, 3e édition, y compris les éléments suivants :

    1. Crises de migraine présentes depuis plus d'un an avec un âge d'apparition avant 50 ans.
    2. Les crises de migraine durent en moyenne de 4 à 72 heures si elles ne sont pas traitées.
    3. Pas plus de 8 attaques d'intensité de douleur modérée ou sévère par mois au cours des 3 derniers mois.
    4. Les participants doivent être capables de distinguer les crises de migraine des céphalées de tension/en grappes.
    5. Au moins 2 crises de migraine constantes d'intensité modérée ou sévère au cours de chacun des 3 mois précédant la visite de dépistage et tout au long de la phase de dépistage (auto-évaluation du participant).
    6. Moins de 15 jours avec des maux de tête (migraineux ou non) par mois au cours de chacun des 3 mois précédant la visite de dépistage et tout au long de la phase de dépistage (auto-évaluation du participant).
    7. Les participants sous traitement prophylactique contre la migraine sont autorisés à poursuivre le traitement s'ils ont reçu une dose stable pendant au moins 3 mois avant la visite de dépistage et si la dose ne devrait pas changer pendant la visite de fin de traitement.
    8. Les participants présentant des contre-indications à l'utilisation de triptans peuvent être inclus à condition qu'ils répondent à tous les autres critères d'admission à l'étude.

Critère d'exclusion:

  • Antécédents de migraine rétinienne, de migraine basilaire ou de migraine hémiplégique.
  • Antécédents ou preuves actuelles d'une maladie cardiovasculaire ou cardiométabolique non contrôlée, instable ou récemment diagnostiquée.
  • Trouble dépressif majeur, trouble anxieux ou autre trouble psychiatrique important.
  • Syndromes de douleur aiguë ou chronique, troubles psychiatriques, démence ou troubles neurologiques importants (autres que la migraine) qui interfèrent avec les évaluations de l'étude.
  • Conditions pouvant affecter l'administration ou l'absorption du produit nasal.
  • Céphalées par abus de médicaments.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo
Médicament: Placebo
Dose unique du placebo correspondant prise pendant la phase de traitement.
Expérimental: Zavegepant
Zavegepant intranasal 10 mg
Médicament: Zavegepant
Les participants recevront une dose active unique suffisante pour traiter 1 migraine d'intensité modérée ou sévère pendant la phase de traitement.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Pain Freedom at 2 Hours Post-dose
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Pain Relief at 15 Minutes Post-dose
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Pfizer

Les enquêteurs

  • Directeur d'études: Pfizer CT.gov Call Center, Pfizer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 novembre 2023

Achèvement primaire (Réel)

30 mai 2025

Achèvement de l'étude (Réel)

30 mai 2025

Dates d'inscription aux études

Première soumission

3 août 2023

Première soumission répondant aux critères de contrôle qualité

3 août 2023

Première publication (Réel)

14 août 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • C5301008
  • NCT05989048 (Identificateur de registre: ClinicalTrials.gov)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Pfizer fournira un accès aux données individuelles des participants anonymisés et aux documents d'étude connexes (par ex. protocole, plan d'analyse statistique (PAS), rapport d'étude clinique (CSR)) à la demande de chercheurs qualifiés, et sous réserve de certains critères, conditions et exceptions. De plus amples détails sur les critères de partage des données de Pfizer et le processus de demande d'accès sont disponibles sur : https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

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 .

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