A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
29 de enero de 2021 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
83
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Gunma
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Takasaki, Gunma, Japón, 370-0829
- National Hospital Organization Takasaki General Medical Center
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Kanagawa
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Kawasaki, Kanagawa, Japón, 210-0852
- Nippon Kokan Clinic
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Kanagawa-ken
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Fujisawa-shi, Kanagawa-ken, Japón, 252-0802
- Fujisawa Shounandai Hospital
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Yokohama-shi, Kanagawa-ken, Japón, 224-0024
- Medical Corporation Yamamoto Kinenkai Yamamoto Kinen Hospital
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Oita
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Beppu-shi, Oita, Japón, 874-0937
- Nakamura Hospital
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Tokyo
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Fuchu City,, Tokyo, Japón, 183-8524
- Tokyo Metropolitan Fuchu Hospital
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Minato-ku, Tokyo, Japón, 106-8581
- FuruKawabashi Hospital
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Minato-ku, Tokyo, Japón, 108-8639
- Research Hospital, The Institute of Medical Science, The University of Tokyo
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Shinagawa-ku, Tokyo, Japón, 140-0001
- Kitashinagawa Third Hospital
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Shinagawa-ku, Tokyo, Japón, 141-0001
- Oosaki Hospital Tokyo Heart Center
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Shinagawa-ku, Tokyo, Japón, 141-8625
- Kanto Medical Center NTT EC
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Shinjuku-ku, Tokyo, Japón, 162-8655
- International Medical Center of Japan Toyama Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
35 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Placebo
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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
|
|
Experimental: 100 microgramos/kg
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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
|
|
Experimental: 200 microgramos/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
|
|
Experimental: 10 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
|
|
Experimental: 25 microgramos/kg
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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
|
|
Experimental: 50 mcg/kg
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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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: 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)
|
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)
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline
Periodo de tiempo: 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.
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Baseline (Part 1 and Part 2)
|
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Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
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Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Week 13 (Part 1 and Part 2)
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Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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 current index knee pain 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 Current Index Knee Pain at Week 2
Periodo de tiempo: 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.
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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 Current Index Knee Pain at Week 3
Periodo de tiempo: 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)
|
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Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
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Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9
Periodo de tiempo: Baseline, Week 9 (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 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
Periodo de tiempo: 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)
|
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11
Periodo de tiempo: 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
Periodo de tiempo: 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)
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Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13
Periodo de tiempo: 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 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
Periodo de tiempo: 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.
|
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
Periodo de tiempo: 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.
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
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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 7
Periodo de tiempo: 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)
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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 8
Periodo de tiempo: 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)
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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 9
Periodo de tiempo: 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)
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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 10
Periodo de tiempo: Baseline, Week 10 (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 10 (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 11
Periodo de tiempo: 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.
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Baseline, Week 11 (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 12
Periodo de tiempo: 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.
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Baseline, Week 12 (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 13
Periodo de tiempo: 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.
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Baseline, Week 13 (Part 1 and 2)
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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1
Periodo de tiempo: Baseline, Week 1 (Part 1 and 2)
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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.
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Baseline, Week 1 (Part 1 and 2)
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Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2
Periodo de tiempo: Baseline, Week 2 (Part 1 and 2)
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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.
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Baseline, Week 2 (Part 1 and 2)
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Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4
Periodo de tiempo: 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.
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Baseline, Week 4 (Part 1 and 2)
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Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8
Periodo de tiempo: 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)
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Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13
Periodo de tiempo: 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.
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Baseline, Week 13 (Part 1 and 2)
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Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17
Periodo de tiempo: 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.
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Baseline, Week 17 (Part 1 and 2)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) - Part 1
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de junio de 2008
Finalización primaria (Actual)
25 de diciembre de 2009
Finalización del estudio (Actual)
25 de diciembre de 2009
Fechas de registro del estudio
Enviado por primera vez
25 de abril de 2008
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2008
Publicado por primera vez (Estimar)
30 de abril de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de febrero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
29 de enero de 2021
Última verificación
1 de enero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A4091022
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan 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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .