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
  Purpose

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).


Condition Intervention Phase
Osteoarthritis, Knee
Drug: PF-04383119 (tanezumab)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 83
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10 mcg/kg Drug: PF-04383119 (tanezumab)
single dose of 10 mcg/kg IV
Experimental: 100 mcg/kg Drug: PF-04383119 (tanezumab)
single dose of 100 mcg/kg IV
Experimental: 200 mcg/kg Drug: PF-04383119 (tanezumab)
single dose of 200 mcg/kg IV
Experimental: 25 mcg/kg Drug: PF-04383119 (tanezumab)
single dose of 25 mcg/kg IV
Experimental: 50 mcg/kg Drug: PF-04383119 (tanezumab)
single dose of 50 mcg/kg IV
Placebo Comparator: Placebo Drug: PF-04383119 (tanezumab)
single dose of Placebo IV

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669409

Locations
Japan
Pfizer Investigational Site
Takasaki-shi, Gunma-ken, Japan
Pfizer Investigational Site
Fujisawa-shi, Kanagawa-ken, Japan
Pfizer Investigational Site
Yokohama-shi, Kanagawa-ken, Japan
Pfizer Investigational Site
Kawasaki-shi, Kanagawa, Japan
Pfizer Investigational Site
Beppu-shi, Oita, Japan
Pfizer Investigational Site
Fuchu City,, Tokyo, Japan
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00669409     History of Changes
Other Study ID Numbers: A4091022
Study First Received: April 25, 2008
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
monoclonal antibody

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 19, 2014