A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
29 gennaio 2021 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
83
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Gunma
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Takasaki, Gunma, Giappone, 370-0829
- National Hospital Organization Takasaki General Medical Center
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Kanagawa
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Kawasaki, Kanagawa, Giappone, 210-0852
- Nippon Kokan Clinic
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Kanagawa-ken
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Fujisawa-shi, Kanagawa-ken, Giappone, 252-0802
- Fujisawa Shounandai Hospital
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Yokohama-shi, Kanagawa-ken, Giappone, 224-0024
- Medical Corporation Yamamoto Kinenkai Yamamoto Kinen Hospital
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Oita
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Beppu-shi, Oita, Giappone, 874-0937
- Nakamura Hospital
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Tokyo
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Fuchu City,, Tokyo, Giappone, 183-8524
- Tokyo Metropolitan Fuchu Hospital
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Minato-ku, Tokyo, Giappone, 106-8581
- FuruKawabashi Hospital
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Minato-ku, Tokyo, Giappone, 108-8639
- Research Hospital, The Institute of Medical Science, The University of Tokyo
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Shinagawa-ku, Tokyo, Giappone, 140-0001
- Kitashinagawa Third Hospital
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Shinagawa-ku, Tokyo, Giappone, 141-0001
- Oosaki Hospital Tokyo Heart Center
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Shinagawa-ku, Tokyo, Giappone, 141-8625
- Kanto Medical Center NTT EC
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Shinjuku-ku, Tokyo, Giappone, 162-8655
- International Medical Center of Japan Toyama Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 35 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore placebo: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 200mcg/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
|
|
Sperimentale: 10mcg/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
|
|
Sperimentale: 25mcg/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
|
|
Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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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
Lasso di tempo: 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
Lasso di tempo: 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.
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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
Lasso di tempo: Baseline, Week 12 (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 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
Lasso di tempo: 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 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, Week 4 (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 4 (Part 1 and 2)
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Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8
Lasso di tempo: Baseline, Week 8 (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 8 (Part 1 and 2)
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Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13
Lasso di tempo: Baseline, Week 13 (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 13 (Part 1 and 2)
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Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17
Lasso di tempo: Baseline, Week 17 (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 17 (Part 1 and 2)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Maximum Observed Plasma Concentration (Cmax) - Part 1
Lasso di tempo: 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
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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
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Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1
Lasso di tempo: 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
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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
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1
Lasso di tempo: 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
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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).
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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
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Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1
Lasso di tempo: 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
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AUClast is defined as the area under the plasma concentration time-curve from zero to the last measured concentration.
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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
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Volume of Distribution (Vz) - Part 1
Lasso di tempo: 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
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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.
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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
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Volume of Distribution At Steady State (Vss) - Part 1
Lasso di tempo: 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
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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.
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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
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Systemic Clearance (CL) - Part 1
Lasso di tempo: 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
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CL is a quantitative measure of the rate at which a drug substance is removed from the body.
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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
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Mean Residence Time (MRT) - Part 1
Lasso di tempo: 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
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MRT was calculated as area under the moment curve/area under the concentration effect curve.
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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
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Plasma Decay Half-Life (t1/2) - Part 1
Lasso di tempo: 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
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Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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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
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Percentage of Participants With Positive Anti-tanezumab Antibody Test Results
Lasso di tempo: Baseline up to Day 120
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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).
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Baseline up to Day 120
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
6 giugno 2008
Completamento primario (Effettivo)
25 dicembre 2009
Completamento dello studio (Effettivo)
25 dicembre 2009
Date di iscrizione allo studio
Primo inviato
25 aprile 2008
Primo inviato che soddisfa i criteri di controllo qualità
29 aprile 2008
Primo Inserito (Stima)
30 aprile 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 febbraio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 gennaio 2021
Ultimo verificato
1 gennaio 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- A4091022
Piano per i dati dei singoli partecipanti (IPD)
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Sì
Descrizione del piano 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.
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .