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

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

PF-04383119 (tanezumab)

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring monoclonal antibody

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Hospital Organization Takasaki General Medical Center
Fujisawa shounandai Hospital
Medical Corporation Yamamoto Kinenkai Yamamoto Kinen Hospital
Nippon Kokan Clinic
Nakamura Hospital
Tokyo Metropolitan Fuchu Hospital
FuruKawabashi Hospital
Research Hospital, the Institute of Medical Science, the University of Tokyo
Kitashinagawa Third Hospital
Oosaki Hospital Tokyo Heart Center
Kanto Medical Center Ntt Ec
International Medical Center of Japan Toyama Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

10 mcg/kg

100 mcg/kg

200 mcg/kg

25 mcg/kg

50 mcg/kg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline

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.

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5

Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6

Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7

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.

Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13

Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12

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.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13

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.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1

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.

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8

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.

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) - Part 1

Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1

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).

Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1

AUClast is defined as the area under the plasma concentration time-curve from zero to the last measured concentration.

Volume of Distribution (Vz) - Part 1

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.

Volume of Distribution At Steady State (Vss) - Part 1

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.

Systemic Clearance (CL) - Part 1

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Mean Residence Time (MRT) - Part 1

MRT was calculated as area under the moment curve/area under the concentration effect curve.

Plasma Decay Half-Life (t1/2) - Part 1

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Percentage of Participants With Positive Anti-tanezumab Antibody Test Results

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).

Full Information

NCT ID

NCT00669409

First Posted

April 25, 2008

Last Updated

January 29, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00669409

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

June 6, 2008 (Actual)

Primary Completion Date

December 25, 2009 (Actual)

Study Completion Date

December 25, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

monoclonal antibody

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10 mcg/kg

Arm Type

Experimental

Arm Title

100 mcg/kg

Arm Type

Experimental

Arm Title

200 mcg/kg

Arm Type

Experimental

Arm Title

25 mcg/kg

Arm Type

Experimental

Arm Title

50 mcg/kg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

PF-04383119 (tanezumab)

Intervention Description

single dose of 10 mcg/kg IV

Intervention Type

Drug

Intervention Name(s)

PF-04383119 (tanezumab)

Intervention Description

single dose of 100 mcg/kg IV

Intervention Type

Drug

Intervention Name(s)

PF-04383119 (tanezumab)

Intervention Description

single dose of 200 mcg/kg IV

Intervention Type

Drug

Intervention Name(s)

PF-04383119 (tanezumab)

Intervention Description

single dose of 25 mcg/kg IV

Intervention Type

Drug

Intervention Name(s)

PF-04383119 (tanezumab)

Intervention Description

single dose of 50 mcg/kg IV

Intervention Type

Drug

Intervention Name(s)

PF-04383119 (tanezumab)

Intervention Description

single dose of Placebo IV

Primary Outcome Measure Information:

Title

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

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)

Title

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline

Description

Time Frame

Baseline (Part 1 and Part 2)

Title

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1

Description

Time Frame

Day 1 (Part 1 and 2)

Title

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5

Description

Time Frame

Day 4/5 (Part 1 and 2)

Title

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1

Description

Time Frame

Week 1 (Part 1 and Part 2)

Title

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2

Description

Time Frame

Week 2 (Part 1 and Part 2)

Title

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3

Description

Time Frame

Week 3 (Part 1 and 2)

Title

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4

Description

Time Frame

Week 4 (Part 1 and Part 2)

Title

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13

Description

Time Frame

Week 13 (Part 1 and Part 2)

Title

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17

Description

Time Frame

Week 17 (Part 1 and Part 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1

Description

Time Frame

Baseline, Week 1 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2

Description

Time Frame

Baseline, Week 2 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3

Description

Time Frame

Baseline, Week 3 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4

Description

Time Frame

Baseline, Week 4 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5

Description

Time Frame

Baseline, Week 5 (Part 1 and 2)

Title

Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6

Description

Time Frame

Baseline, Week 6 (Part 1 and 2)

Title

Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7

Description

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.

Time Frame

Baseline, Week 7 (Part 1 and 2)

Title

Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8

Description

Time Frame

Baseline, Week 8 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9

Description

Time Frame

Baseline, Week 9 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10

Description

Time Frame

Baseline, Week 10 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11

Description

Time Frame

Baseline, Week 11 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12

Description

Time Frame

Baseline, Week 12 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13

Description

Time Frame

Baseline, Week 13 (Part 1 and 2)

Title

Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1

Description

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.

Time Frame

Baseline, Week 1 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2

Description

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.

Time Frame

Baseline, Week 2 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3

Description

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.

Time Frame

Baseline, Week 3 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4

Description

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.

Time Frame

Baseline, Week 4 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5

Description

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.

Time Frame

Baseline, Week 5 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6

Description

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.

Time Frame

Baseline, Week 6 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7

Description

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.

Time Frame

Baseline, Week 7 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8

Description

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.

Time Frame

Baseline, Week 8 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9

Description

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.

Time Frame

Baseline, Week 9 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10

Description

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.

Time Frame

Baseline, Week 10 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11

Description

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.

Time Frame

Baseline, Week 11 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12

Description

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.

Time Frame

Baseline, Week 12 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13

Description

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.

Time Frame

Baseline, Week 13 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1

Description

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.

Time Frame

Baseline, Week 1 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 2

Description

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.

Time Frame

Baseline, Week 2 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3

Description

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.

Time Frame

Baseline, Week 3 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4

Description

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.

Time Frame

Baseline, Week 4 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5

Description

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.

Time Frame

Baseline, Week 5 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6

Description

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.

Time Frame

Baseline, Week 6 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7

Description

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.

Time Frame

Baseline, Week 7 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8

Description

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.

Time Frame

Baseline, Week 8 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9

Description

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.

Time Frame

Baseline, Week 9 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10

Description

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.

Time Frame

Baseline, Week 10 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11

Description

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.

Time Frame

Baseline, Week 11 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12

Description

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.

Time Frame

Baseline, Week 12 (Part 1 and 2)

Title

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13

Description

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.

Time Frame

Baseline, Week 13 (Part 1 and 2)

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1

Description

Time Frame

Baseline, Week 1 (Part 1 and 2)

Title

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2

Description

Time Frame

Baseline, Week 2 (Part 1 and 2)

Title

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4

Description

Time Frame

Baseline, Week 4 (Part 1 and 2)

Title

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8

Description

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.

Time Frame

Baseline, Week 8 (Part 1 and 2)

Title

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13

Description

Time Frame

Baseline, Week 13 (Part 1 and 2)

Title

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17

Description

Time Frame

Baseline, Week 17 (Part 1 and 2)

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1

Description

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

Title

Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1

Description

AUClast is defined as the area under the plasma concentration time-curve from zero to the last measured concentration.

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

Title

Volume of Distribution (Vz) - Part 1

Description

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.

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

Title

Volume of Distribution At Steady State (Vss) - Part 1

Description

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

Title

Systemic Clearance (CL) - Part 1

Description

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

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

Title

Mean Residence Time (MRT) - Part 1

Description

MRT was calculated as area under the moment curve/area under the concentration effect curve.

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

Title

Plasma Decay Half-Life (t1/2) - Part 1

Description

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

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

Title

Percentage of Participants With Positive Anti-tanezumab Antibody Test Results

Description

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).

Time Frame

Baseline up to Day 120

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

National Hospital Organization Takasaki General Medical Center

City

Takasaki

State/Province

Gunma

ZIP/Postal Code

370-0829

Country

Japan

Facility Name

Fujisawa shounandai Hospital

City

Fujisawa-shi

State/Province

Kanagawa-ken

ZIP/Postal Code

252-0802

Country

Japan

Facility Name

Medical Corporation Yamamoto Kinenkai Yamamoto Kinen Hospital

City

Yokohama-shi

State/Province

Kanagawa-ken

ZIP/Postal Code

224-0024

Country

Japan

Facility Name

Nippon Kokan Clinic

City

Kawasaki

State/Province

Kanagawa

ZIP/Postal Code

210-0852

Country

Japan

Facility Name

Nakamura Hospital

City

Beppu-shi

State/Province

Oita

ZIP/Postal Code

874-0937

Country

Japan

Facility Name

Tokyo Metropolitan Fuchu Hospital

City

Fuchu City,

State/Province

Tokyo

ZIP/Postal Code

183-8524

Country

Japan

Facility Name

FuruKawabashi Hospital

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

106-8581

Country

Japan

Facility Name

Research Hospital, the Institute of Medical Science, the University of Tokyo

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

108-8639

Country

Japan

Facility Name

Kitashinagawa Third Hospital

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

140-0001

Country

Japan

Facility Name

Oosaki Hospital Tokyo Heart Center

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

141-0001

Country

Japan

Facility Name

Kanto Medical Center Ntt Ec

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

141-8625

Country

Japan

Facility Name

International Medical Center of Japan Toyama Hospital

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

162-8655

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

22004765

Citation

Nagashima H, Suzuki M, Araki S, Yamabe T, Muto C; Tanezumab Investigators. Preliminary assessment of the safety and efficacy of tanezumab in Japanese patients with moderate to severe osteoarthritis of the knee: a randomized, double-blind, dose-escalation, placebo-controlled study. Osteoarthritis Cartilage. 2011 Dec;19(12):1405-12. doi: 10.1016/j.joca.2011.09.006. Epub 2011 Oct 5.

Results Reference

derived

Learn more about this trial

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

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