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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00669409

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	Phase II

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

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: 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 ]

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: 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 ]

Estimated Enrollment:	80
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
10 mcg/kg: Experimental	Drug: PF-04383119 single dose of 10 mcg/kg IV
100 mcg/kg: Experimental	Drug: PF-04383119 single dose of 100 mcg/kg IV
200 mcg/kg: Experimental	Drug: PF-04383119 single dose of 200 mcg/kg IV
25 mcg/kg: Experimental	Drug: PF-04383119 single dose of 25 mcg/kg IV
50 mcg/kg: Experimental	Drug: PF-04383119 single dose of 50 mcg/kg IV
Placebo: Placebo Comparator	Drug: PF-04383119 single dose of Placebo IV

Eligibility

Ages Eligible for Study:	35 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Japanese Male or female, Age 35-65
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
VAS for walking pain in past 24 hours ≥40 at screening with or without medication; VAS for walking pain in past 24 hours ≥50 and ≤90 at baseline (average of Day -7 to Day -1) ; An increase of ≥10 points in VAS for walking pain at baseline (average of Day -7 to Day -1) for patients who have been on pain medications prior to screening; Patients on no pain medication do not need to meet this criteria as long as they have a VAS of ≥50 at 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

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Japan, Kanagawa
Pfizer Investigational Site	Not yet recruiting
Kawasaki-shi, Kanagawa, Japan
Japan, Tokyo
Pfizer Investigational Site	Recruiting
Shinagawa-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4091022
Study First Received:	April 25, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00669409
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

monoclonal antibody

Study placed in the following topic categories:

Antibodies, Monoclonal
Osteoarthritis, Knee
Antibodies
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Pain
Rheumatic Diseases
Immunoglobulins

ClinicalTrials.gov processed this record on January 16, 2009