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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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00669409
First received: April 25, 2008
Last updated: January 10, 2011
Last verified: January 2011
History of Changes

April 25, 2008
January 10, 2011
June 2008
December 2009   (final data collection date for primary outcome measure)
  • Safety assessments for the study include AE collection, vital signs, postural vital signs, weight, physical and neurological examinations, ECG, Hopkins Verbal Learning Test -Revised (HVLT-R™), and routine laboratory tests. [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
  • Western Ontario and McMaster Universities Arthritis (WOMAC 3.1™) scale. [ Time Frame: 120 days ] [ Designated as safety issue: No ]
  • VAS for index knee pain during walking in the past 24 hours. [ Time Frame: 120 days ] [ Designated as safety issue: No ]
  • VAS for index knee pain in the past 24 hours. [ Time Frame: 120 days ] [ Designated as safety issue: No ]
  • Visual analogue scale (VAS) for current index knee pain. [ Time Frame: 120 days ] [ Designated as safety issue: No ]
  • Safety assessments for the study include AE collection, vital signs, postural vital signs, weight, physical and neurological examinations, ECG, Hopkins Verbal Learning Test -Revised (HVLT-R™), and routine laboratory tests. [ Time Frame: 120days ] [ Designated as safety issue: Yes ]
  • Western Ontario and McMaster Universities Arthritis (WOMAC 3.1™) scale. [ Time Frame: 120days ] [ Designated as safety issue: No ]
  • VAS for index knee pain during walking in the past 24 hours. [ Time Frame: 120days ] [ Designated as safety issue: No ]
  • VAS for index knee pain in the past 24 hours. [ Time Frame: 120days ] [ Designated as safety issue: No ]
  • Visual analogue scale (VAS) for current index knee pain. [ Time Frame: 120days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00669409 on ClinicalTrials.gov Archive Site
  • Following PK parameters will be determined from the plasma PF-04383119 concentration-time profiles by model-independent analysis: Cmax, Tmax, AUCinf, AUClast, V0, Vss, CL, MRT, and t1/2. [ Time Frame: 120 days ] [ Designated as safety issue: No ]
  • All patients exposed to PF-04383119 will be tested for development of anti-PF-04383119 antibodies. [ Time Frame: 120 days ] [ Designated as safety issue: No ]
  • Following PK parameters will be determined from the plasma PF-04383119 concentration-time profiles by model-independent analysis: Cmax, Tmax, AUCinf, AUClast, V0, Vss, CL, MRT, and t1/2. [ Time Frame: 120days ] [ Designated as safety issue: No ]
  • All patients exposed to PF-04383119 will be tested for development of anti-PF-04383119 antibodies. [ Time Frame: 120days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis, Knee
  • 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
    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. 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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00669409
A4091022
Yes
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