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En studie for å lære om Zavegepant som akutt behandling av migrene hos asiatiske voksne

29. april 2026 oppdatert av: Pfizer

En fase 3, randomisert, dobbeltblind, placebokontrollert, parallell gruppestudie for å evaluere effektiviteten og sikkerheten til Zavegepant Intranasal (IN) for akutt behandling av migrene hos asiatiske voksne

Hensikten med denne studien er å lære hvor sikker og effektiv zavegepant er sammenlignet med placebo ved akutt behandling av migrene hos asiatiske voksne. Migrene er en veldig smertefull hodepine med andre assosierte symptomer som kvalme, fotofobi og fonofobi. En placebo er en ufarlig behandling som ikke har noen medisinsk effekt.

Denne studien søker etter deltakere som:

  • ha minst 1 års migrenehistorie før du går inn i studiet.
  • har 2 til 8 migrenehodepineanfall av moderat eller alvorlig intensitet i hver av de 3 månedene før du går inn i studien.
  • har mindre enn 15 dager med hodepine i hver av de 3 månedene før de går inn i studien. Hodepinen kan enten skyldes migrene eller ikke.

Deltakerne i denne studien vil få zavegepant eller placebo intranasal rute. Intranasal betyr medisin som gis gjennom nesen. Zavegepant eller placebo vil bli tatt hvis deltakerne har en migrenehodepine av moderat eller alvorlig intensitet.

Studien vil sammenligne opplevelsene til personer som får zavegepant med erfaringene til personer som får placebo. Dette vil hjelpe å se om zavegepant er trygt og effektivt hos asiatiske voksne.

Deltakerne vil være i denne studien i opptil ca. 16 uker. Deltakerne vil ha 3 studiebesøk på studieklinikken og 1 gjennom telefonkontakt.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1414

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Asiatiske deltakere i alderen 18 år eller eldre ved screening.

  • Deltakere med minimum 1 års historie med migrene (med eller uten aura) før screeningbesøket, i samsvar med en diagnose i henhold til International Classification of Headache Disorders, 3. utgave, inkludert følgende:

    1. Migreneanfall forekommer i mer enn 1 år med alderen før 50 års alder.
    2. Migreneanfall varer i gjennomsnitt 4-72 timer hvis de ikke behandles.
    3. Ikke mer enn 8 angrep med moderat eller alvorlig smerteintensitet per måned i løpet av de siste 3 månedene.
    4. Deltakerne må kunne skille migreneanfall fra spennings-/klyngehodepine.
    5. Minst 2 konsekvente migrenehodepineanfall av moderat eller alvorlig intensitet i hver av de 3 månedene før screeningbesøket og gjennom screeningsfasen (deltakers egenrapport).
    6. Mindre enn 15 dager med hodepine (migrene eller ikke-migrene) per måned i hver av de 3 månedene før screeningbesøket og gjennom screeningsfasen (deltakers egenrapportering).
    7. Deltakere på profylaktisk migrenemedisin har tillatelse til å fortsette i behandlingen hvis de har vært på en stabil dose i minst 3 måneder før screeningbesøket, og hvis dosen ikke forventes å endres gjennom avsluttet behandlingsbesøk.
    8. Deltakere med kontraindikasjoner for bruk av triptaner kan inkluderes forutsatt at de oppfyller alle andre kriterier for studiestart.

Ekskluderingskriterier:

  • Anamnese med retinal migrene, basilar migrene eller hemiplegisk migrene.
  • Historie eller nåværende bevis på ukontrollert, ustabil eller nylig diagnostisert kardiovaskulær eller kardiometabolsk sykdom.
  • Alvorlig depressiv lidelse, angstlidelse eller annen betydelig psykiatrisk lidelse.
  • Akutte eller kroniske smertesyndromer, psykiatriske tilstander, demens eller betydelige nevrologiske lidelser (annet enn migrene) som forstyrrer studievurderinger.
  • Tilstander som kan påvirke administrering eller absorpsjon av neseproduktet.
  • Medisiner overforbruk hodepine.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Legemiddel: Placebo
Enkeltdose med matchende placebo tatt i behandlingsfasen.
Eksperimentell: Zavegepant
Zavegepant intranasal 10 mg
Legemiddel: Zavegepant
Deltakerne vil få en enkelt aktiv dose tilstrekkelig til å behandle 1 migrenehodepine av moderat eller alvorlig intensitet i behandlingsfasen.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Pain Freedom at 2 Hours Post-dose
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Pain Relief at 15 Minutes Post-dose
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. november 2023

Primær fullføring (Faktiske)

30. mai 2025

Studiet fullført (Faktiske)

30. mai 2025

Datoer for studieregistrering

Først innsendt

3. august 2023

Først innsendt som oppfylte QC-kriteriene

3. august 2023

Først lagt ut (Faktiske)

14. august 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C5301008
  • NCT05989048 (Registeridentifikator: ClinicalTrials.gov)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer vil gi tilgang til individuelle avidentifiserte deltakerdata og relaterte studiedokumenter (f.eks. protokoll, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) på forespørsel fra kvalifiserte forskere, og underlagt visse kriterier, betingelser og unntak. Ytterligere detaljer om Pfizers datadelingskriterier og prosess for å be om tilgang finnes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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