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아시아 성인 편두통의 급성 치료제인 자베지판트에 대해 알아보기 위한 연구

2026년 4월 29일 업데이트: Pfizer

아시아 성인의 급성 편두통 치료를 위한 Zavegepant 비강내(IN)의 효능 및 안전성을 평가하기 위한 3상, 무작위, 이중 맹검, 위약 대조, 병렬 그룹 연구

이 연구의 목적은 아시아 성인의 편두통 급성 치료에서 위약과 비교하여 zavegepant가 얼마나 안전하고 효과적인지 알아보는 것입니다. 편두통은 메스꺼움, 광선 공포증 및 소리 공포증과 같은 다른 관련 증상을 동반하는 매우 고통스러운 두통입니다. 위약은 의학적 효과가 없는 무해한 치료법입니다.

이 연구는 다음과 같은 참가자를 찾고 있습니다.

  • 연구에 참여하기 전에 최소 1년의 편두통 병력이 있어야 합니다.
  • 연구에 들어가기 전 3개월마다 중등도 또는 중증 강도의 편두통 발작이 2~8회 발생했습니다.
  • 연구 시작 전 3개월 동안 두통이 있었던 날이 15일 미만입니다. 두통은 편두통 때문일 수도 있고 아닐 수도 있습니다.

이 연구의 참가자는 비강 경로를 통해 zavegepant 또는 위약을 받게 됩니다. 비강은 코를 통해 투여되는 약을 의미합니다. 참가자가 중등도 또는 중증의 편두통이 있는 경우 Zavegepant 또는 위약을 복용합니다.

이 연구는 zavegepant를 받은 사람들의 경험을 위약을 받은 사람들의 경험과 비교할 것입니다. 이것은 zavegepant가 아시아 성인에게 안전하고 효과적인지 확인하는 데 도움이 될 것입니다.

참가자는 최대 약 16주 동안 이 연구에 참여하게 됩니다. 참가자는 연구 클리닉에서 3회 연구 방문을 하고 전화 연락을 통해 1회 방문합니다.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

1414

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 심사 시 18세 이상의 아시아인 참가자.

  • 다음을 포함하여 국제 두통 장애 분류, 제3판에 따른 진단과 일치하는, 스크리닝 방문 전에 최소 1년의 편두통(조짐이 있거나 없는) 이력이 있는 참가자:

    1. 편두통 발작은 50세 이전에 발병하여 1년 이상 지속됩니다.
    2. 편두통 발작은 치료하지 않으면 평균적으로 약 4-72시간 지속됩니다.
    3. 지난 3개월 동안 한 달에 중등도 또는 중증의 통증 강도가 8회 이하입니다.
    4. 참가자는 편두통 발작과 긴장성/군발성 두통을 구별할 수 있어야 합니다.
    5. 스크리닝 방문 전 3개월 각각 및 스크리닝 단계 전체에 적어도 2회의 중등도 또는 중증 강도의 일관된 편두통 발작(참가자 자기 보고).
    6. 스크리닝 방문 전 3개월 및 스크리닝 단계 전체에 걸쳐 매월 15일 미만의 두통(편두통 또는 비편두통).
    7. 예방적 편두통 약물 치료를 받는 참가자는 스크리닝 방문 전 최소 3개월 동안 안정적인 용량을 유지했고 용량이 치료 방문 종료 시까지 변경되지 않을 것으로 예상되는 경우 치료를 계속 받을 수 있습니다.
    8. 트립탄 사용에 대한 금기 사항이 있는 참가자는 다른 모든 연구 참가 기준을 충족하는 경우 포함될 수 있습니다.

제외 기준:

  • 망막 편두통, 기저 편두통 또는 편마비 편두통의 병력.
  • 통제되지 않거나 불안정하거나 최근에 진단된 심혈관 또는 심혈관 대사 질환의 병력 또는 현재 증거.
  • 주요 우울 장애, 불안 장애 또는 기타 중요한 정신 장애.
  • 연구 평가를 방해하는 급성 또는 만성 통증 증후군, 정신 질환, 치매 또는 중요한 신경학적 장애(편두통 제외).
  • 비강 제품의 투여 또는 흡수에 영향을 미칠 수 있는 상태.
  • 약물 남용 두통.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
의약품: 위약
치료 단계 내에 취한 일치하는 위약의 단일 용량.
실험적: 자베지팬트
자베지판트 비강내 10 mg
의약품: 자베지팬트
참가자는 치료 단계 내에서 중등도 또는 중증 강도의 편두통 1회를 치료하기에 충분한 단일 활성 용량을 투여받습니다.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Pain Freedom at 2 Hours Post-dose
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Pain Relief at 15 Minutes Post-dose
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

수사관

  • 연구 책임자: Pfizer CT.gov Call Center, Pfizer

간행물 및 유용한 링크

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유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 11월 29일

기본 완료 (실제)

2025년 5월 30일

연구 완료 (실제)

2025년 5월 30일

연구 등록 날짜

최초 제출

2023년 8월 3일

QC 기준을 충족하는 최초 제출

2023년 8월 3일

처음 게시됨 (실제)

2023년 8월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 29일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • C5301008
  • NCT05989048 (레지스트리 식별자: ClinicalTrials.gov)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

화이자는 식별되지 않은 개별 참가자 데이터 및 관련 연구 문서(예: 프로토콜, 통계 분석 계획(SAP), 임상 연구 보고서(CSR)) 자격을 갖춘 연구자의 요청에 따라 특정 기준, 조건 및 예외가 적용됩니다. 화이자의 데이터 공유 기준 및 액세스 요청 프로세스에 대한 자세한 내용은 https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests에서 확인할 수 있습니다.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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