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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

NCT ID: NCT00669409

Last Updated: 2021-02-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-06

Study Completion Date

2009-12-25

Brief Summary

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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).

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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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10 mcg/kg

Group Type EXPERIMENTAL

PF-04383119 (tanezumab)

Intervention Type DRUG

single dose of 10 mcg/kg IV

100 mcg/kg

Group Type EXPERIMENTAL

PF-04383119 (tanezumab)

Intervention Type DRUG

single dose of 100 mcg/kg IV

200 mcg/kg

Group Type EXPERIMENTAL

PF-04383119 (tanezumab)

Intervention Type DRUG

single dose of 200 mcg/kg IV

25 mcg/kg

Group Type EXPERIMENTAL

PF-04383119 (tanezumab)

Intervention Type DRUG

single dose of 25 mcg/kg IV

50 mcg/kg

Group Type EXPERIMENTAL

PF-04383119 (tanezumab)

Intervention Type DRUG

single dose of 50 mcg/kg IV

Placebo

Group Type PLACEBO_COMPARATOR

PF-04383119 (tanezumab)

Intervention Type DRUG

single dose of Placebo IV

Interventions

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PF-04383119 (tanezumab)

single dose of 10 mcg/kg IV

Intervention Type DRUG

PF-04383119 (tanezumab)

single dose of 100 mcg/kg IV

Intervention Type DRUG

PF-04383119 (tanezumab)

single dose of 200 mcg/kg IV

Intervention Type DRUG

PF-04383119 (tanezumab)

single dose of 25 mcg/kg IV

Intervention Type DRUG

PF-04383119 (tanezumab)

single dose of 50 mcg/kg IV

Intervention Type DRUG

PF-04383119 (tanezumab)

single dose of Placebo IV

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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National Hospital Organization Takasaki General Medical Center

Takasaki, Gunma, Japan

Site Status

Fujisawa shounandai Hospital

Fujisawa-shi, Kanagawa, Japan

Site Status

Nippon Kokan Clinic

Kawasaki, Kanagawa, Japan

Site Status

Medical Corporation Yamamoto Kinenkai Yamamoto Kinen Hospital

Yokohama, Kanagawa, Japan

Site Status

Nakamura Hospital

Beppu-shi, Oita Prefecture, Japan

Site Status

Tokyo Metropolitan Fuchu Hospital

Fuchū, Tokyo, Japan

Site Status

FuruKawabashi Hospital

Minato-ku, Tokyo, Japan

Site Status

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

Minato-ku, Tokyo, Japan

Site Status

Kitashinagawa Third Hospital

Shinagawa-ku, Tokyo, Japan

Site Status

Oosaki Hospital Tokyo Heart Center

Shinagawa-ku, Tokyo, Japan

Site Status

Kanto Medical Center Ntt Ec

Shinagawa-ku, Tokyo, Japan

Site Status

International Medical Center of Japan Toyama Hospital

Shinjuku-ku, Tokyo, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 22004765 (View on PubMed)

Other Identifiers

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A4091022

Identifier Type: -

Identifier Source: org_study_id

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