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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis, Knee

Treatments

Drug: PF-04383119 (tanezumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00669409

A4091022

Details and patient eligibility

About

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).

Enrollment

83 patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

83 participants in 6 patient groups, including a placebo group

10 mcg/kg

Experimental group

Treatment:

Drug: PF-04383119 (tanezumab)

100 mcg/kg

Experimental group

Treatment:

Drug: PF-04383119 (tanezumab)

200 mcg/kg

Experimental group

Treatment:

Drug: PF-04383119 (tanezumab)

25 mcg/kg

Experimental group

Treatment:

Drug: PF-04383119 (tanezumab)

50 mcg/kg

Experimental group

Treatment:

Drug: PF-04383119 (tanezumab)

Placebo

Placebo Comparator group

Treatment:

Drug: PF-04383119 (tanezumab)

Trial contacts and locations

12

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