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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

NCT00669409 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2021-02-21

Study results available
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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).

Conditions

  • Osteoarthritis, Knee

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-06
Primary Completion
2009-12-25
Completion
2009-12-25

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00669409 on ClinicalTrials.gov