Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Een studie om meer te weten te komen over Zavegepant als de acute behandeling van migraine bij Aziatische volwassenen

29 april 2026 bijgewerkt door: Pfizer

Een fase 3, gerandomiseerde, dubbelblinde, placebogecontroleerde, parallelle groepsstudie om de werkzaamheid en veiligheid van Zavegepant intranasaal (IN) voor de acute behandeling van migraine bij Aziatische volwassenen te evalueren

Het doel van deze studie is om te leren hoe veilig en effectief Zavegepant wordt vergeleken met placebo bij de acute behandeling van migraine bij Aziatische volwassenen. Migraine is een zeer pijnlijke hoofdpijn met andere bijbehorende symptomen zoals misselijkheid, fotofobie en fonofobie. Een placebo is een onschadelijke behandeling die geen medisch effect heeft.

Deze studie is op zoek naar deelnemers die:

  • minstens 1 jaar migrainegeschiedenis hebben voordat u aan het onderzoek begint.
  • 2 tot 8 migrainehoofdpijnaanvallen van matige of ernstige intensiteit hebben in elk van de 3 maanden voordat u aan het onderzoek begint.
  • minder dan 15 dagen hoofdpijn hebben in elk van de 3 maanden voordat u aan het onderzoek begint. De hoofdpijn kan te wijten zijn aan migraine of niet.

De deelnemers aan deze studie zullen via intranasale weg zavegepant of placebo krijgen. Intranasaal betekent geneesmiddel dat via de neus wordt toegediend. Zavegepant of placebo zal worden ingenomen als de deelnemers migrainehoofdpijn hebben van matige of ernstige intensiteit.

De studie zal de ervaringen van mensen die Zavegepant kregen vergelijken met die van mensen die een placebo kregen. Dit zal helpen om te zien of Zavegepant veilig en effectief is bij Aziatische volwassenen.

Deelnemers zullen maximaal ongeveer 16 weken in deze studie zijn. Deelnemers krijgen 3 studiebezoeken in de studiekliniek en 1 via telefonisch contact.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1414

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

  • Aziatische deelnemers van 18 jaar of ouder bij screening.

  • Deelnemers met minimaal 1 jaar voorgeschiedenis van migraine (met of zonder aura) voorafgaand aan het screeningsbezoek, in overeenstemming met een diagnose volgens de International Classification of Headache Disorders, 3rd Edition, waaronder de volgende:

    1. Migraine-aanvallen die langer dan 1 jaar aanwezig zijn, beginnend vóór de leeftijd van 50 jaar.
    2. Migraine-aanvallen duren gemiddeld 4-72 uur als ze niet worden behandeld.
    3. Niet meer dan 8 aanvallen van matige of ernstige pijnintensiteit per maand in de afgelopen 3 maanden.
    4. Deelnemers moeten migraineaanvallen kunnen onderscheiden van spannings-/clusterhoofdpijn.
    5. Ten minste 2 aanhoudende migraineaanvallen van matige of ernstige intensiteit in elk van de 3 maanden voorafgaand aan het screeningsbezoek en tijdens de screeningsfase (zelfrapportage door de deelnemer).
    6. Minder dan 15 dagen met hoofdpijn (migraine of niet-migraine) per maand in elk van de 3 maanden voorafgaand aan het screeningsbezoek en gedurende de screeningsfase (zelfrapportage deelnemer).
    7. Deelnemers aan profylactische migrainemedicatie mogen in therapie blijven als ze gedurende ten minste 3 maanden voorafgaand aan het screeningsbezoek een stabiele dosis hebben gehad en als de dosis naar verwachting niet zal veranderen tijdens het bezoek aan het einde van de behandeling.
    8. Deelnemers met contra-indicaties voor het gebruik van triptanen kunnen worden opgenomen op voorwaarde dat ze voldoen aan alle andere toelatingscriteria voor het onderzoek.

Uitsluitingscriteria:

  • Geschiedenis van retinale migraine, basale migraine of hemiplegische migraine.
  • Geschiedenis of actueel bewijs van ongecontroleerde, onstabiele of recent gediagnosticeerde cardiovasculaire of cardiometabolische ziekte.
  • Ernstige depressieve stoornis, angststoornis of andere significante psychiatrische stoornis.
  • Acute of chronische pijnsyndromen, psychiatrische aandoeningen, dementie of significante neurologische aandoeningen (anders dan migraine) die studiebeoordelingen verstoren.
  • Aandoeningen die de toediening of absorptie van het neusproduct kunnen beïnvloeden.
  • Medicatie overmatig gebruik hoofdpijn.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Geneesmiddel: Placebo
Enkele dosis overeenkomende placebo ingenomen binnen de behandelingsfase.
Experimenteel: Vegetarisch
Zavegepant intranasaal 10 mg
Geneesmiddel: Vegetarisch
De deelnemers krijgen een enkele actieve dosis die voldoende is om 1 migrainehoofdpijn van matige of ernstige intensiteit te behandelen tijdens de behandelingsfase.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Pain Freedom at 2 Hours Post-dose
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Pain Relief at 15 Minutes Post-dose
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pfizer

Onderzoekers

  • Studie directeur: Pfizer CT.gov Call Center, Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 november 2023

Primaire voltooiing (Werkelijk)

30 mei 2025

Studie voltooiing (Werkelijk)

30 mei 2025

Studieregistratiedata

Eerst ingediend

3 augustus 2023

Eerst ingediend dat voldeed aan de QC-criteria

3 augustus 2023

Eerst geplaatst (Werkelijk)

14 augustus 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

29 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • C5301008
  • NCT05989048 (Register-ID: ClinicalTrials.gov)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Pfizer zal toegang verlenen tot gegevens van individuele geanonimiseerde deelnemers en gerelateerde onderzoeksdocumenten (bijv. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) op verzoek van gekwalificeerde onderzoekers en onder voorbehoud van bepaalde criteria, voorwaarden en uitzonderingen. Meer details over Pfizer's criteria voor het delen van gegevens en het proces voor het aanvragen van toegang zijn te vinden op: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren