Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee

29 januari 2021 uppdaterad av: 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

83

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Japan
    • Gunma
      • Takasaki, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Center
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 210-0852
        • Nippon Kokan Clinic
    • Kanagawa-ken
      • Fujisawa-shi, Kanagawa-ken, Japan, 252-0802
        • Fujisawa Shounandai Hospital
      • Yokohama-shi, Kanagawa-ken, Japan, 224-0024
        • Medical Corporation Yamamoto Kinenkai Yamamoto Kinen Hospital
    • Oita
      • Beppu-shi, Oita, Japan, 874-0937
        • Nakamura Hospital
    • Tokyo
      • Fuchu City,, Tokyo, Japan, 183-8524
        • Tokyo Metropolitan Fuchu Hospital
      • Minato-ku, Tokyo, Japan, 106-8581
        • FuruKawabashi Hospital
      • Minato-ku, Tokyo, Japan, 108-8639
        • Research Hospital, The Institute of Medical Science, The University of Tokyo
      • Shinagawa-ku, Tokyo, Japan, 140-0001
        • Kitashinagawa Third Hospital
      • Shinagawa-ku, Tokyo, Japan, 141-0001
        • Oosaki Hospital Tokyo Heart Center
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • Kanto Medical Center NTT EC
      • Shinjuku-ku, Tokyo, Japan, 162-8655
        • International Medical Center of Japan Toyama Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

35 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Läkemedel: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of Placebo IV
Experimentell: 100 mcg/kg
Läkemedel: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of Placebo IV
Experimentell: 200 mcg/kg
Läkemedel: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of Placebo IV
Experimentell: 10 mcg/kg
Läkemedel: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of Placebo IV
Experimentell: 25 mcg/kg
Läkemedel: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of Placebo IV
Experimentell: 50 mcg/kg
Läkemedel: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Läkemedel: PF-04383119 (tanezumab)
single dose of Placebo IV

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 2
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum Observed Plasma Concentration (Cmax) - Part 1
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 juni 2008

Primärt slutförande (Faktisk)

25 december 2009

Avslutad studie (Faktisk)

25 december 2009

Studieregistreringsdatum

Först inskickad

25 april 2008

Först inskickad som uppfyllde QC-kriterierna

29 april 2008

Första postat (Uppskatta)

30 april 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 februari 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 januari 2021

Senast verifierad

1 januari 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • A4091022

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

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.

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Artros, knä

Kliniska prövningar på PF-04383119 (tanezumab)

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Benin

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera