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

NCT00669409

Last updated date
Study Location
Pfizer Investigational Site
Takasaki-shi, Gunma-ken, , Japan
Contact
1-800-718-1021

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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 <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
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

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2010)
83
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2008)
80
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00669409
Other Study ID Numbers  ICMJE A4091022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP