Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
NCT ID: NCT03031938
Last Updated: 2021-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4 participants
INTERVENTIONAL
2017-11-03
2020-06-04
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, 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, diclofenac, administered in parent study
Eligibility Criteria
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Inclusion Criteria
* The infant's mother (who was the tanezumab clinical study participant) must review, agree and sign an informed consent document explaining the details of the perinatal and post natal follow up. Where local regulations mandate, the male parent would also review and sign the informed consent.
* Parents or legal guardian must be willing and able to comply with scheduled visits and study procedures.
0 Years
2 Months
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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USC Keck School of Medicine
Los Angeles, California, United States
Gulfcoast Research Institute
Sarasota, Florida, United States
Kennedy and White Orthopaedic Center
Sarasota, Florida, United States
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, United States
Lafayette Clinical Research Group
Lafayette, Indiana, United States
Preferred Pediatrics
Lafayette, Indiana, United States
Countries
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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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2013-002548-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INFANT SAFETY FOLLOW-UP #2
Identifier Type: OTHER
Identifier Source: secondary_id
NEONATAL MONITORING STUDY #2
Identifier Type: OTHER
Identifier Source: secondary_id
A4091065
Identifier Type: -
Identifier Source: org_study_id
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