A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
29. januar 2021 opdateret af: 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).
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
83
Fase
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Gunma
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Takasaki, Gunma, Japan, 370-0829
- National Hospital Organization Takasaki General Medical Center
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Kanagawa
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Kawasaki, Kanagawa, Japan, 210-0852
- Nippon Kokan Clinic
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Kanagawa-ken
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Fujisawa-shi, Kanagawa-ken, Japan, 252-0802
- Fujisawa Shounandai Hospital
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Yokohama-shi, Kanagawa-ken, Japan, 224-0024
- Medical Corporation Yamamoto Kinenkai Yamamoto Kinen Hospital
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Oita
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Beppu-shi, Oita, Japan, 874-0937
- Nakamura Hospital
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Tokyo
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Fuchu City,, Tokyo, Japan, 183-8524
- Tokyo Metropolitan Fuchu Hospital
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Minato-ku, Tokyo, Japan, 106-8581
- FuruKawabashi Hospital
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Minato-ku, Tokyo, Japan, 108-8639
- Research Hospital, The Institute of Medical Science, The University of Tokyo
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Shinagawa-ku, Tokyo, Japan, 140-0001
- Kitashinagawa Third Hospital
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Shinagawa-ku, Tokyo, Japan, 141-0001
- Oosaki Hospital Tokyo Heart Center
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Shinagawa-ku, Tokyo, Japan, 141-8625
- Kanto Medical Center NTT EC
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Shinjuku-ku, Tokyo, Japan, 162-8655
- International Medical Center of Japan Toyama Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
35 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Antal våben
6
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Placebo komparator: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: 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)
|
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Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, Week 10 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 10 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11
Tidsramme: Baseline, Week 11 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 11 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12
Tidsramme: Baseline, Week 12 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 12 (Part 1 and 2)
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13
Tidsramme: Baseline, Week 13 (Part 1 and 2)
|
VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity.
Higher score indicated greater pain intensity.
VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.
|
Baseline, Week 13 (Part 1 and 2)
|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1
Tidsramme: Baseline, Week 1 (Part 1 and 2)
|
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions).
Functional domain provided information of ability to perform activities of daily living.
The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme).
Each domain scored by averaging VAS scores of component questions.
Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
|
Baseline, Week 1 (Part 1 and 2)
|
|
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2
Tidsramme: Baseline, Week 2 (Part 1 and 2)
|
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions).
Functional domain provided information of ability to perform activities of daily living.
The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme).
Each domain scored by averaging VAS scores of component questions.
Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
|
Baseline, Week 2 (Part 1 and 2)
|
|
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4
Tidsramme: Baseline, Week 4 (Part 1 and 2)
|
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions).
Functional domain provided information of ability to perform activities of daily living.
The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme).
Each domain scored by averaging VAS scores of component questions.
Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
|
Baseline, Week 4 (Part 1 and 2)
|
|
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8
Tidsramme: Baseline, Week 8 (Part 1 and 2)
|
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions).
Functional domain provided information of ability to perform activities of daily living.
The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0=none to 100= extreme).
Each domain scored by averaging VAS scores of component questions.
Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
|
Baseline, Week 8 (Part 1 and 2)
|
|
Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13
Tidsramme: 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
Tidsramme: Baseline, Week 17 (Part 1 and 2)
|
WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions).
Functional domain provided information of ability to perform activities of daily living.
The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme).
Each domain scored by averaging VAS scores of component questions.
Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.
|
Baseline, Week 17 (Part 1 and 2)
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) - Part 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
6. juni 2008
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
25. december 2009
Studieafslutning (Faktiske)
Studieafslutning
25. december 2009
Datoer for studieregistrering
Først indsendt
Først indsendt
25. april 2008
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
29. april 2008
Først opslået (Skøn)
Først opslået
30. april 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
21. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. januar 2021
Sidst verificeret
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- A4091022
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
IPD-planbeskrivelse
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.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .