At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 83 enrolled
Drug / intervention
PF-04383119 (tanezumab) +5 moredrug
Likely dose
PF-04383119 (tanezumab) 10 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating PF-04383119 (tanezumab) for Osteoarthritis, Knee. Completed, enrolled 83 participants across 12 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartJun 2008
Primary CompletionDec 2009
TodayJul 2026
First PostedApr 30, 2008
Enrollment StartJun 6, 2008
Primary CompletionDec 25, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.2 years ago
Interventions
PF-04383119 (tanezumab)drug
single dose of 10 mcg/kg IV
PF-04383119 (tanezumab)drug
single dose of 100 mcg/kg IV
PF-04383119 (tanezumab)drug
single dose of 200 mcg/kg IV
PF-04383119 (tanezumab)drug
single dose of 25 mcg/kg IV
PF-04383119 (tanezumab)drug
single dose of 50 mcg/kg IV
PF-04383119 (tanezumab)drug
single dose of Placebo IV