A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
29 января 2021 г. обновлено: Pfizer
A PHASE 1/2A, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE BLIND, DOSE-ESCALATION, MULTICENTER STUDY OF THE SAFETY, TOLERABILITY, EFFICACY AND PHARMACOKINETICS, OF A SINGLE INTRAVENOUS DOSE OF PF-04383119 IN JAPANESE PATIENTS WITH MODERATE TO SEVERE PAIN FROM OSTEOARTHRITIS OF THE KNEE
To evaluate the safety and tolerability of single IV doses of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee (Part I).
To evaluate the preliminary analgesic efficacy of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee in comparison with placebo (Part I and Part II).
Обзор исследования
Статус
Завершенный
Условия
Тип исследования
Интервенционный
Регистрация (Действительный)
83
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Gunma
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Takasaki, Gunma, Япония, 370-0829
- National Hospital Organization Takasaki General Medical Center
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Kanagawa
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Kawasaki, Kanagawa, Япония, 210-0852
- Nippon Kokan Clinic
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Kanagawa-ken
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Fujisawa-shi, Kanagawa-ken, Япония, 252-0802
- Fujisawa Shounandai Hospital
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Yokohama-shi, Kanagawa-ken, Япония, 224-0024
- Medical Corporation Yamamoto Kinenkai Yamamoto Kinen Hospital
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Oita
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Beppu-shi, Oita, Япония, 874-0937
- Nakamura Hospital
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Tokyo
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Fuchu City,, Tokyo, Япония, 183-8524
- Tokyo Metropolitan Fuchu Hospital
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Minato-ku, Tokyo, Япония, 106-8581
- FuruKawabashi Hospital
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Minato-ku, Tokyo, Япония, 108-8639
- Research Hospital, The Institute of Medical Science, The University of Tokyo
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Shinagawa-ku, Tokyo, Япония, 140-0001
- Kitashinagawa Third Hospital
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Shinagawa-ku, Tokyo, Япония, 141-0001
- Oosaki Hospital Tokyo Heart Center
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Shinagawa-ku, Tokyo, Япония, 141-8625
- Kanto Medical Center NTT EC
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Shinjuku-ku, Tokyo, Япония, 162-8655
- International Medical Center of Japan Toyama Hospital
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 35 лет до 75 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Japanese Male or female, Age 35-65 (Part 1), Age 35-75 (Part 2)
- Diagnosis of osteoarthritis (OA) of the knee based on American College of Rheumatology criteria
- Knee pain, and radiographic evidence of knee OA (Kellgren-Lawrence x-ray grade ≥2) obtained within 1 year of enrollment
- At least one of the following: age >50, morning stiffness <30 minutes in duration, crepitus, and OA of the knee must involve the index tibiofemoral joint and must have present for at least 6 months
- Patients who meet at least one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery
- Pain levels as required by the protocol at Screening and Baseline
Exclusion Criteria:
- Diagnosis or history of RA, any inflammatory arthritis, gout, Paget's disease or any other disease that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of OA
- Patients with regional pain syndromes suggestive of fibromyalgia or regional pain caused by lumbar or cervical compressions with radiculopathy or at risk of developing radiculopathy.
- Diagnosis or history of fibromyalgia
- Planned surgical procedure during the duration of the study
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Плацебо Компаратор: Плацебо
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single dose of 10 mcg/kg IV
single dose of 100 mcg/kg IV
single dose of 200 mcg/kg IV
single dose of 25 mcg/kg IV
single dose of 50 mcg/kg IV
single dose of Placebo IV
|
|
Экспериментальный: 100 мкг/кг
|
single dose of 10 mcg/kg IV
single dose of 100 mcg/kg IV
single dose of 200 mcg/kg IV
single dose of 25 mcg/kg IV
single dose of 50 mcg/kg IV
single dose of Placebo IV
|
|
Экспериментальный: 200 мкг/кг
|
single dose of 10 mcg/kg IV
single dose of 100 mcg/kg IV
single dose of 200 mcg/kg IV
single dose of 25 mcg/kg IV
single dose of 50 mcg/kg IV
single dose of Placebo IV
|
|
Экспериментальный: 10 мкг/кг
|
single dose of 10 mcg/kg IV
single dose of 100 mcg/kg IV
single dose of 200 mcg/kg IV
single dose of 25 mcg/kg IV
single dose of 50 mcg/kg IV
single dose of Placebo IV
|
|
Экспериментальный: 25 мкг/кг
|
single dose of 10 mcg/kg IV
single dose of 100 mcg/kg IV
single dose of 200 mcg/kg IV
single dose of 25 mcg/kg IV
single dose of 50 mcg/kg IV
single dose of Placebo IV
|
|
Экспериментальный: 50 mcg/kg
|
single dose of 10 mcg/kg IV
single dose of 100 mcg/kg IV
single dose of 200 mcg/kg IV
single dose of 25 mcg/kg IV
single dose of 50 mcg/kg IV
single dose of Placebo IV
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Временное ограничение: Day 1 up to Day 92 for tanezumab 10, 25, 50 mcg/kg group and matching placebo group (Part 1, 2); Day 1 up to Day 120 for tanezumab 100 mcg/kg group and matching placebo group (Part 1, 2), 200 mcg/kg group and matching placebo group (Part 1)
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An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent: events between first dose of study drug and up to Day 1 through Day 120 (Part 1 and 2) were absent before treatment or that worsened relative to pretreatment state
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Day 1 up to Day 92 for tanezumab 10, 25, 50 mcg/kg group and matching placebo group (Part 1, 2); Day 1 up to Day 120 for tanezumab 100 mcg/kg group and matching placebo group (Part 1, 2), 200 mcg/kg group and matching placebo group (Part 1)
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|
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline
Временное ограничение: Baseline (Part 1 and Part 2)
|
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall).
It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition.
The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn.
The total score ranges from 0 (no memory) to 36 (best memory).
Higher score indicated best memory.
|
Baseline (Part 1 and Part 2)
|
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Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1
Временное ограничение: Day 1 (Part 1 and 2)
|
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall).
It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition.
The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn.
The total score ranges from 0 (no memory) to 36 (best memory).
Higher score indicated best memory.
|
Day 1 (Part 1 and 2)
|
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Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5
Временное ограничение: Day 4/5 (Part 1 and 2)
|
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall).
It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition.
The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn.
The total score ranges from 0 (no memory) to 36 (best memory).
Higher score indicated best memory.
|
Day 4/5 (Part 1 and 2)
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1
Временное ограничение: Week 1 (Part 1 and Part 2)
|
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall).
It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition.
The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn.
The total score ranges from 0 (no memory) to 36 (best memory).
Higher score indicated best memory.
|
Week 1 (Part 1 and Part 2)
|
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Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2
Временное ограничение: Week 2 (Part 1 and Part 2)
|
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall).
It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition.
The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn.
The total score ranges from 0 (no memory) to 36 (best memory).
Higher score indicated best memory.
|
Week 2 (Part 1 and Part 2)
|
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Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3
Временное ограничение: Week 3 (Part 1 and 2)
|
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall).
It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition.
The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn.
The total score ranges from 0 (no memory) to 36 (best memory).
Higher score indicated best memory.
|
Week 3 (Part 1 and 2)
|
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Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4
Временное ограничение: Week 4 (Part 1 and Part 2)
|
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall).
It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition.
The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn.
The total score ranges from 0 (no memory) to 36 (best memory).
Higher score indicated best memory.
|
Week 4 (Part 1 and Part 2)
|
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Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13
Временное ограничение: Week 13 (Part 1 and Part 2)
|
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall).
It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition.
The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn.
The total score ranges from 0 (no memory) to 36 (best memory).
Higher score indicated best memory.
|
Week 13 (Part 1 and Part 2)
|
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Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17
Временное ограничение: Week 17 (Part 1 and Part 2)
|
The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall).
It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition.
The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn.
The total score ranges from 0 (no memory) to 36 (best memory).
Higher score indicated best memory.
|
Week 17 (Part 1 and Part 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1
Временное ограничение: Baseline, Week 1 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 1 (Part 1 and 2)
|
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Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2
Временное ограничение: Baseline, Week 2 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 2 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3
Временное ограничение: Baseline, Week 3 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 3 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4
Временное ограничение: Baseline, Week 4 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 4 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5
Временное ограничение: Baseline, Week 5 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 5 (Part 1 and 2)
|
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Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6
Временное ограничение: Baseline, Week 6 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 6 (Part 1 and 2)
|
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Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7
Временное ограничение: Baseline, Week 7 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 10 0= extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 7 (Part 1 and 2)
|
|
Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8
Временное ограничение: Baseline, Week 8 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 8 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9
Временное ограничение: Baseline, Week 9 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 9 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10
Временное ограничение: Baseline, Week 10 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 10 (Part 1 and 2)
|
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Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11
Временное ограничение: Baseline, Week 11 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 11 (Part 1 and 2)
|
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Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12
Временное ограничение: Baseline, Week 12 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 12 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13
Временное ограничение: Baseline, Week 13 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for current index knee pain was recorded on the electronic diary.
|
Baseline, Week 13 (Part 1 and 2)
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Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1
Временное ограничение: Baseline, Week 1 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 1 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2
Временное ограничение: Baseline, Week 2 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 2 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3
Временное ограничение: Baseline, Week 3 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 3 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4
Временное ограничение: Baseline, Week 4 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 4 (Part 1 and 2)
|
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5
Временное ограничение: Baseline, Week 5 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 5 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6
Временное ограничение: Baseline, Week 6 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 6 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7
Временное ограничение: Baseline, Week 7 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 7 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8
Временное ограничение: Baseline, Week 8 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 8 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9
Временное ограничение: Baseline, Week 9 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 9 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10
Временное ограничение: Baseline, Week 10 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 10 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11
Временное ограничение: Baseline, Week 11 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 11 (Part 1 and 2)
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|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12
Временное ограничение: Baseline, Week 12 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 12 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13
Временное ограничение: Baseline, Week 13 (Part 1 and 2)
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VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 13 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1
Временное ограничение: Baseline, Week 1 (Part 1 and 2)
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VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
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Baseline, Week 1 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 2
Временное ограничение: Baseline, Week 2 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
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Baseline, Week 2 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3
Временное ограничение: Baseline, Week 3 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 3 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4
Временное ограничение: Baseline, Week 4 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 4 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5
Временное ограничение: Baseline, Week 5 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 5 (Part 1 and 2)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6
Временное ограничение: Baseline, Week 6 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 6 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7
Временное ограничение: Baseline, Week 7 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 7 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8
Временное ограничение: Baseline, Week 8 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 8 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9
Временное ограничение: Baseline, Week 9 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 9 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10
Временное ограничение: Baseline, Week 10 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 10 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11
Временное ограничение: Baseline, Week 11 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 11 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12
Временное ограничение: Baseline, Week 12 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 12 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13
Временное ограничение: Baseline, Week 13 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 13 (Part 1 and 2)
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1
Временное ограничение: Baseline, Week 1 (Part 1 and 2)
|
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions).
Functional domain provided information of ability to perform activities of daily living.
The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme).
Each domain scored by averaging VAS scores of component questions.
Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
|
Baseline, Week 1 (Part 1 and 2)
|
|
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2
Временное ограничение: Baseline, Week 2 (Part 1 and 2)
|
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions).
Functional domain provided information of ability to perform activities of daily living.
The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme).
Each domain scored by averaging VAS scores of component questions.
Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
|
Baseline, Week 2 (Part 1 and 2)
|
|
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4
Временное ограничение: Baseline, Week 4 (Part 1 and 2)
|
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions).
Functional domain provided information of ability to perform activities of daily living.
The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme).
Each domain scored by averaging VAS scores of component questions.
Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
|
Baseline, Week 4 (Part 1 and 2)
|
|
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8
Временное ограничение: Baseline, Week 8 (Part 1 and 2)
|
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions).
Functional domain provided information of ability to perform activities of daily living.
The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0=none to 100= extreme).
Each domain scored by averaging VAS scores of component questions.
Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
|
Baseline, Week 8 (Part 1 and 2)
|
|
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13
Временное ограничение: Baseline, Week 13 (Part 1 and 2)
|
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions).
Functional domain provided information of ability to perform activities of daily living.
The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme).
Each domain scored by averaging VAS scores of component questions.
Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
|
Baseline, Week 13 (Part 1 and 2)
|
|
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17
Временное ограничение: Baseline, Week 17 (Part 1 and 2)
|
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions).
Functional domain provided information of ability to perform activities of daily living.
The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme).
Each domain scored by averaging VAS scores of component questions.
Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
|
Baseline, Week 17 (Part 1 and 2)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) - Part 1
Временное ограничение: Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1
Временное ограничение: Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1
Временное ограничение: Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
AUC (0-infinity) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity).
It is obtained from AUC (0-t) plus AUC (t-infinity).
|
Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
|
Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1
Временное ограничение: Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
AUClast is defined as the area under the plasma concentration time-curve from zero to the last measured concentration.
|
Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
|
Volume of Distribution (Vz) - Part 1
Временное ограничение: Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
Vz is defined as the the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
|
Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
|
Volume of Distribution At Steady State (Vss) - Part 1
Временное ограничение: Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
Vss is defined as the the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
It is the apparent volume of distribution at steady-state.
|
Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
|
Systemic Clearance (CL) - Part 1
Временное ограничение: Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
|
Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
|
Mean Residence Time (MRT) - Part 1
Временное ограничение: Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
MRT was calculated as area under the moment curve/area under the concentration effect curve.
|
Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
|
Plasma Decay Half-Life (t1/2) - Part 1
Временное ограничение: Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
|
Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
|
|
Percentage of Participants With Positive Anti-tanezumab Antibody Test Results
Временное ограничение: Baseline up to Day 120
|
Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).
|
Baseline up to Day 120
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
6 июня 2008 г.
Первичное завершение (Действительный)
25 декабря 2009 г.
Завершение исследования (Действительный)
25 декабря 2009 г.
Даты регистрации исследования
Первый отправленный
25 апреля 2008 г.
Впервые представлено, что соответствует критериям контроля качества
29 апреля 2008 г.
Первый опубликованный (Оценивать)
30 апреля 2008 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
21 февраля 2021 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
29 января 2021 г.
Последняя проверка
1 января 2021 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- A4091022
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Да
Описание плана IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования PF-04383119 (tanezumab)
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PfizerЗавершенныйЗдоровыйСоединенные Штаты
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PfizerЗавершенный
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PfizerЕще не набирают
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PfizerЗавершенныйСахарный диабет, тип 1Соединенные Штаты
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PfizerЗавершенныйЗдоровые участникиНидерланды
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PfizerЗавершенный
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PfizerАктивный, не рекрутирующий
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PfizerЗавершенныйЗдоровые участникиСоединенные Штаты
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PfizerЕще не набираютЗдоровые участникиСоединенные Штаты