A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
29 janvier 2021 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
83
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Gunma
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Takasaki, Gunma, Japon, 370-0829
- National Hospital Organization Takasaki General Medical Center
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Kanagawa
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Kawasaki, Kanagawa, Japon, 210-0852
- Nippon Kokan Clinic
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Kanagawa-ken
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Fujisawa-shi, Kanagawa-ken, Japon, 252-0802
- Fujisawa Shounandai Hospital
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Yokohama-shi, Kanagawa-ken, Japon, 224-0024
- Medical Corporation Yamamoto Kinenkai Yamamoto Kinen Hospital
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Oita
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Beppu-shi, Oita, Japon, 874-0937
- Nakamura Hospital
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Tokyo
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Fuchu City,, Tokyo, Japon, 183-8524
- Tokyo Metropolitan Fuchu Hospital
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Minato-ku, Tokyo, Japon, 106-8581
- FuruKawabashi Hospital
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Minato-ku, Tokyo, Japon, 108-8639
- Research Hospital, The Institute of Medical Science, The University of Tokyo
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Shinagawa-ku, Tokyo, Japon, 140-0001
- Kitashinagawa Third Hospital
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Shinagawa-ku, Tokyo, Japon, 141-0001
- Oosaki Hospital Tokyo Heart Center
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Shinagawa-ku, Tokyo, Japon, 141-8625
- Kanto Medical Center NTT EC
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Shinjuku-ku, Tokyo, Japon, 162-8655
- International Medical Center of Japan Toyama Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
35 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo
|
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
|
|
Expérimental: 100 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
|
|
Expérimental: 200 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
|
|
Expérimental: 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
|
|
Expérimental: 25 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
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Délai: 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
|
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
Délai: 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)
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1
Délai: 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)
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5
Délai: 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
Délai: 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)
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2
Délai: 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)
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3
Délai: 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)
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4
Délai: 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)
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13
Délai: 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)
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3
Délai: 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
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5
Délai: 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)
|
|
Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6
Délai: 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)
|
|
Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7
Délai: 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
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13
Délai: 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
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8
Délai: 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
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10
Délai: 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
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12
Délai: 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
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1
Délai: 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 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
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5
Délai: 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)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
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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
Délai: Baseline, Week 11 (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 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
Délai: 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)
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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
Délai: 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)
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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
Délai: 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
Délai: 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.
|
Baseline, Week 2 (Part 1 and 2)
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Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4
Délai: 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)
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Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) - Part 1
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
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Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
6 juin 2008
Achèvement primaire (Réel)
25 décembre 2009
Achèvement de l'étude (Réel)
25 décembre 2009
Dates d'inscription aux études
Première soumission
25 avril 2008
Première soumission répondant aux critères de contrôle qualité
29 avril 2008
Première publication (Estimation)
30 avril 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 février 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 janvier 2021
Dernière vérification
1 janvier 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- A4091022
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Oui
Description du régime 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.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .