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NCT02674386 · ClinicalTrials.gov registry record · Phase 3
Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
A Phase 3 study of Osteoarthritis, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT02674386: Completed Phase 3 study of Osteoarthritis, sponsored by Pfizer.
NCT02674386 is a Phase 3 study of Osteoarthritis that has completed, run by Pfizer. The registered enrollment target is 154 participants, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02674386, a Phase 3 study of Osteoarthritis, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Following the TJR surgery on Day 1, the orthopedic surgeon was asked to answer the following question: "taking into consideration the participant's medical history and physical condition prior to surgery would you classify the operative procedure as Uneventful, Minor complications or Major complications." Participants were reported based on these categories for knee, hip and shoulder joint. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Conditions Studied
Interventions
- DRUG Investigational Medical Product (IMP) administered in parent study
Study Locations (20)
California
- Advanced Research Center, Inc. - Anaheim
- Hope Clinical Research - Canoga Park
- Marvel Clinical Research, LLC - Huntington Beach
- Advances in Medicine - Palm Desert
- Clinical Trials Research - Sacramento
- California Research Foundation - San Diego
- CITrials - Santa Ana
Florida
- JEM Research Institute - Atlantis
- Orthopedic Research Institute - Boynton Beach
- Orthopaedic Associates of West Florida - Clearwater
- Clinical Neuroscience Solutions, Inc. - Jacksonville
- Clintex Research Group - Miami
- Renstar Medical Research - Ocala
Alabama
- Central Alabama Research - Birmingham
- Alabama Clinical Therapeutics, LLC - Birmingham
- Alabama Orthopaedic Surgeons - Birmingham
- Cahaba Research Inc. - Birmingham
Arizona
- Noble Clinical Research - Tucson
Arkansas
- Baptist Health Center for Clinical Research - Little Rock
Connecticut
- Stamford Therapeutics Consortium - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2016-08-23 |
| Est. Completion | 2019-07-15 |
| Phase | Phase 3 |
What the finished NCT02674386 record still lists
NCT02674386 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which Investigational Medical Product (IMP) administered in parent study is the first listed.
NCT02674386 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT02674386 about?
NCT02674386 is a clinical study titled "Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement". 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 w...
What is the current status of trial NCT02674386?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 154 participants. The study started on 2016-08-23. Estimated completion is 2019-07-15.
What conditions does trial NCT02674386 study?
This clinical trial studies the following conditions: Osteoarthritis.
What interventions are being tested in trial NCT02674386?
The interventions under investigation include: Investigational Medical Product (IMP) administered in parent study (DRUG).
Who is sponsoring clinical trial NCT02674386?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02674386 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02674386's enrollment target sits among peer trials
154 72nd of 135 higher than 64 of 135 other Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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