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

January 29, 2021 updated by: 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Japanese Male or female, Age 35-65 (Part 1), Age 35-75 (Part 2)
  • Diagnosis of osteoarthritis (OA) of the knee based on American College of Rheumatology criteria
  • Knee pain, and radiographic evidence of knee OA (Kellgren-Lawrence x-ray grade ≥2) obtained within 1 year of enrollment
  • At least one of the following: age >50, morning stiffness <30 minutes in duration, crepitus, and OA of the knee must involve the index tibiofemoral joint and must have present for at least 6 months
  • Patients who meet at least one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery
  • Pain levels as required by the protocol at Screening and Baseline

Exclusion Criteria:

  • Diagnosis or history of RA, any inflammatory arthritis, gout, Paget's disease or any other disease that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of OA
  • Patients with regional pain syndromes suggestive of fibromyalgia or regional pain caused by lumbar or cervical compressions with radiculopathy or at risk of developing radiculopathy.
  • Diagnosis or history of fibromyalgia
  • Planned surgical procedure during the duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of Placebo IV
Experimental: 100 mcg/kg
Drug: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of Placebo IV
Experimental: 200 mcg/kg
Drug: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of Placebo IV
Experimental: 10 mcg/kg
Drug: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of Placebo IV
Experimental: 25 mcg/kg
Drug: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of Placebo IV
Experimental: 50 mcg/kg
Drug: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Drug: PF-04383119 (tanezumab)
single dose of Placebo IV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) - Part 1
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 25, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A4091022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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