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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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Takasaki-shi, Gunma-ken, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Knee Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00669409
Pfizer
Completed
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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A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
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).
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis, Knee
  • Drug: PF-04383119 (tanezumab)
    single dose of 10 mcg/kg IV
  • Drug: PF-04383119 (tanezumab)
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  • 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
    Intervention: Drug: PF-04383119 (tanezumab)
  • Experimental: 100 mcg/kg
    Intervention: Drug: PF-04383119 (tanezumab)
  • Experimental: 200 mcg/kg
    Intervention: Drug: PF-04383119 (tanezumab)
  • Experimental: 25 mcg/kg
    Intervention: Drug: PF-04383119 (tanezumab)
  • Experimental: 50 mcg/kg
    Intervention: Drug: PF-04383119 (tanezumab)
  • Placebo Comparator: Placebo
    Intervention: Drug: PF-04383119 (tanezumab)
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00669409
A4091022
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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