Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
NCT ID: NCT02674386
Last Updated: 2020-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
154 participants
INTERVENTIONAL
2016-08-23
2019-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Cohort 1
long-term observational study of subjects from tanezumab parent study
Investigational Medical Product (IMP) administered in parent study
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.
Interventions
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Investigational Medical Product (IMP) administered in parent study
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.
Eligibility Criteria
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Inclusion Criteria
* Randomized and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.
* Actual or planned total knee, hip or shoulder replacement surgery during the tanezumab study.
* Willing and able to comply with scheduled visits and other study procedures.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Central Alabama Research
Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Alabama Orthopaedic Surgeons
Birmingham, Alabama, United States
Cahaba Research Inc.
Birmingham, Alabama, United States
Noble Clinical Research
Tucson, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Advanced Research Center, Inc.
Anaheim, California, United States
Hope Clinical Research
Canoga Park, California, United States
Marvel Clinical Research, LLC
Huntington Beach, California, United States
Advances in Medicine
Palm Desert, California, United States
Clinical Trials Research
Sacramento, California, United States
California Research Foundation
San Diego, California, United States
CITrials
Santa Ana, California, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
Orthopedic Research Institute
Boynton Beach, Florida, United States
Orthopaedic Associates of West Florida
Clearwater, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Clintex Research Group
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
American Family Medical
Ocala, Florida, United States
Sunshine Research Center
Opa-locka, Florida, United States
Gulfcoast Research Institute, LLC
Sarasota, Florida, United States
Kennedy White Orthopaedic Center
Sarasota, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Masters of Clinical Research, Inc.
Augusta, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
North Georgia Internal Medicine
Woodstock, Georgia, United States
Injury Care Research
Boise, Idaho, United States
Chicago Clinical Research Institute, Inc.
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, United States
George Stanley Walker, MD
New Orleans, Louisiana, United States
Great Lakes Research Group, Incorporated
Bay City, Michigan, United States
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Drug Trials America
Hartsdale, New York, United States
Remington-Davis, Incorporated
Columbus, Ohio, United States
Optimed Research LTD
Columbus, Ohio, United States
AC Clinical Research
Tiffin, Ohio, United States
Founders Research Corporation
Philadelphia, Pennsylvania, United States
Abigail R. Neiman, MD, PA
Houston, Texas, United States
Advances In Health
Houston, Texas, United States
Mercury Clinical Research, Inc.
Houston, Texas, United States
BI Research Center
Houston, Texas, United States
ClinRx Research
Richardson, Texas, United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States
Mercury Clinical Research
Webster, Texas, United States
Spectrum Medical, Inc.
Danville, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia
Dawson Road Medical Centre
Guelph, Ontario, Canada
Rebecca Medical Associates
Oakville, Ontario, Canada
Recherche Clinique Sigma inc
Québec, Quebec, Canada
Centre de recherche Saint-Louis
Québec, Quebec, Canada
Rheumazentrum Prof. Dr. med Gunther Neeck
Bad Doberan, , Germany
Tolna Megyei Balassa Janos Korhaz, Ortopediai Osztaly
Szekszárd, , Hungary
Azienda Ospedaliero-Universitaria E Policlinico Umberto I
Rome, , Italy
Omuro Orthopedic Clinic
Himeji, Hyōgo, Japan
Nakajo Orthopedic Clinic
Sendai, Miyagi, Japan
Marunouchi Hospital
Matsumoto, Nagano, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Saules seimos medicinos centras
Kaunas, , Lithuania
South Pacific Clinical Trials
Auckland, , New Zealand
Star Unit, North Shore Hospital, Waitemata District Health Board
Auckland, , New Zealand
Southern Clinical Trials- Waitemata Ltd
Auckland, , New Zealand
Clinical Horizons NZ Ltd
Tauranga, , New Zealand
Hospital Conde de Bertiandos
Ponte de Lima, Viana do Castelo District, Portugal
Medical Technologies Ltd.
Saint Petersburg, , Russia
Institute of Rheumatology
Belgrade, , Serbia
Kompan, s.r.o.
Dolný Kubín, , Slovakia
Slovak Research Center Team Member, MUDr. Viliam Cibik, PhD, s.r.o.
Pruské, , Slovakia
Instituto de Ciencias Medicas
Alicante, , Spain
Hospital del Mar
Barcelona, , Spain
Ladulaas Kliniska Studier
Boras, Sweden, , Sweden
ProbarE I Lund AB
Lund, , Sweden
ProbarE i Stockholm AB
Stockholm, , Sweden
Countries
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References
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Mont MA, Carrino JA, Nemeth MA, Burr A, Yamabe T, Viktrup L, Brown MT, West CR, Verburg KM. Postoperative Outcome of Patients Who Underwent Total Joint Replacement During the Tanezumab Phase 3 Osteoarthritis Development Program: A 24-Week Observational Study. Surg Technol Int. 2021 May 20;38:467-477. doi: 10.52198/21.STI.38.OS1439.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2013-002549-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TJR FOLLOW-UP
Identifier Type: OTHER
Identifier Source: secondary_id
A4091064
Identifier Type: -
Identifier Source: org_study_id
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