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アジア成人の片頭痛の急性治療薬としてのザベゲパントについて学ぶ研究

2026年4月29日 更新者：Pfizer

アジア人成人の片頭痛の急性治療におけるザベゲパント鼻腔内投与（IN）の有効性と安全性を評価するための第 3 相ランダム化二重盲検プラセボ対照並行グループ試験

この研究の目的は、アジア人成人の片頭痛の急性治療において、ザベゲパントがプラセボと比較してどれほど安全で効果的であるかを知ることです。 片頭痛は、吐き気、羞明、音声恐怖症などの他の関連症状を伴う非常に痛みを伴う頭痛です。 プラセボは、医学的効果を持たない無害な治療法です。

この研究では、次のような参加者を求めています。

  • 研究に参加する前に少なくとも1年間の片頭痛歴があること。
  • -研究に参加する前の各3か月間に、中等度または重度の偏頭痛発作が2〜8回発生している。
  • 研究に参加する前の各 3 か月間に頭痛を経験した日が 15 日未満である。 頭痛は片頭痛によるものである可能性もあれば、そうでない可能性もあります。

この研究の参加者は、鼻腔内経路を通じてザベゲパントまたはプラセボを投与されます。 鼻腔内とは、鼻から投与される薬を意味します。 参加者が中等度または重度の片頭痛を患っている場合は、ザベゲパントまたはプラセボが服用されます。

この研究では、ザベゲパントを投与された人々の経験をプラセボを投与された人々の経験と比較します。 これは、ザベゲパントがアジア人の成人にとって安全で効果的かどうかを確認するのに役立ちます。

参加者は最長約16週間この研究に参加します。 参加者は、治験クリニックへの治験訪問が 3 回、電話連絡による訪問が 1 回行われます。

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

1414

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • アジア系の参加者はスクリーニング時点で18歳以上。

  • スクリーニング来院前に少なくとも1年間の片頭痛歴（前兆の有無にかかわらず）があり、国際頭痛分類第3版による診断と一致する以下の参加者。

    1. 片頭痛発作は 1 年以上続き、発症年齢は 50 歳未満です。
    2. 片頭痛の発作は、未治療の場合、平均して約 4 ～ 72 時間続きます。
    3. 過去 3 か月以内に、中等度または重度の痛みの発作が月に 8 回を超えないこと。
    4. 参加者は片頭痛発作と緊張性/群発頭痛を区別できなければなりません。
    5. スクリーニング来院前およびスクリーニング段階を通じて、それぞれの 3 か月間に中程度または重度の片頭痛発作が少なくとも 2 回連続して発生している（参加者の自己申告）。
    6. スクリーニング訪問前の各 3 か月およびスクリーニング段階を通じて、頭痛 (片頭痛または非片頭痛) が月あたり 15 日未満である (参加者の自己申告)。
    7. 片頭痛の予防薬を服用している参加者は、スクリーニング来院前の少なくとも 3 か月間安定した用量を服用しており、治療終了来院まで用量が変更されないと予想される場合には、治療を継続することが許可されます。
    8. トリプタン製剤の使用に禁忌がある参加者は、他のすべての研究参加基準を満たしていれば参加することができます。

除外基準:

  • 網膜片頭痛、脳底片頭痛、または片麻痺性片頭痛の病歴。
  • 制御されていない、不安定な、または最近診断された心血管疾患または心臓代謝性疾患の病歴または現在の証拠。
  • 大うつ病性障害、不安障害、またはその他の重大な精神障害。
  • 研究の評価を妨げる急性または慢性の疼痛症候群、精神病状、認知症、または重大な神経障害（片頭痛以外）。
  • 鼻腔用製品の投与または吸収に影響を与える可能性のある症状。
  • 薬物乱用による頭痛。

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：プラセボ
薬：プラセボ
治療段階内に適合するプラセボを単回投与。
実験的：ザベゲパント
ザベゲパント鼻腔内用10mg
薬：ザベゲパント
参加者は、治療段階内で中等度または重度の片頭痛 1 件を治療するのに十分な有効用量を 1 回投与されます。

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With Pain Freedom at 2 Hours Post-dose
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With Pain Relief at 15 Minutes Post-dose
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

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スポンサー

Pfizer

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  • スタディディレクター：Pfizer CT.gov Call Center、Pfizer

出版物と役立つリンク

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便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年11月29日

一次修了 (実際)

2025年5月30日

研究の完了 (実際)

2025年5月30日

試験登録日

最初に提出

2023年8月3日

QC基準を満たした最初の提出物

2023年8月3日

最初の投稿 (実際)

2023年8月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月22日

QC基準を満たした最後の更新が送信されました

2026年4月29日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • C5301008
  • NCT05989048 (レジストリ識別子：ClinicalTrials.gov)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

ファイザーは、匿名化された個々の参加者データおよび関連する研究文書（例: プロトコル、統計分析計画 (SAP)、臨床研究報告書 (CSR)) は資格のある研究者からの要請に応じて作成されますが、特定の基準、条件、例外が適用されます。 ファイザーのデータ共有基準とアクセス要求プロセスの詳細については、https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests を参照してください。

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

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