CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 154 enrolled
Drug / intervention
Investigational Medical Product (IMP) administered in parent studydrug
Likely dose
Not stated in 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.

Search/NCT02674386
NCT02674386Phase 3Completed
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A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT

Pfizer·interventional·Posted Feb 4, 2016·Updated Jul 30, 2020

In Brief

A Phase 3 clinical trial evaluating Investigational Medical Product (IMP) administered in parent study for Osteoarthritis. Completed, enrolled 154 participants across 79 sites in 15 countries.

Detailed Summary

A4091064 is a multicenter, long-term observational study of subjects from tanezumab interventional studies (regardless of treatment group) who undergo a total knee, hip or shoulder replacement during participation in the study. The study is designed with a total duration of subject follow-up of 24 weeks after the total joint replacement surgery. There will be two methods of data collection utilized in this study: interview by site staff via the telephone and interactive web-response system (or paper if the subject has no access to the internet).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesAustralia, Canada, Germany, Hungary, Italy, Japan, Lithuania, New Zealand, Portugal, Russia, Serbia, Slovakia, Spain, Sweden, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 4, 2016
Enrollment StartAug 23, 2016
Primary CompletionJul 15, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.4 years ago

Interventions

Investigational Medical Product (IMP) administered in parent studydrug

IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.