A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth
A Protocol to Monitor the Neurological Development of Infants With Exposure In-utero From Birth to Aged 15 Months in Tanezumab Clinical Studies at Investigational Sites Overseen by Schulman and Associates Institutional Review Board
2 other identifiers
observational
7
1 country
8
Brief Summary
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2011
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2011
CompletedFirst Posted
Study publicly available on registry
May 30, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFebruary 6, 2013
February 1, 2013
1 year
May 24, 2011
February 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Bayley Infant Neurodevelopmental Screener
0-2 Months
Bayley Infant Neurodevelopmental Screener
8 months
Bayley Infant Neurodevelopmental Screener
15 months
Receptive-Expressive Emergent Language Test
0-2 Months
Receptive-Expressive Emergent Language Test
8 months
Receptive-Expressive Emergent Language Test
15 months
Study Arms (1)
Infants with potential exposure in utero
Interventions
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).
Eligibility Criteria
Infants with potential exposure in utero through their parents partcipation in a tanezumab clinical study
You may qualify if:
- Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study through direct maternal exposure; or is an infant born to a mother who is a partner of a male patient who was exposed to study drug in a tanezumab clinical study prior to or around the time of conception and/or is exposed during his partner's pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (8)
Pfizer Investigational Site
Tempe, Arizona, 85282, United States
Pfizer Investigational Site
Tempe, Arizona, 85283, United States
Pfizer Investigational Site
Wildomar, California, 92595, United States
Pfizer Investigational Site
Cutler Bay, Florida, 33189, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635, United States
Pfizer Investigational Site
Memphis, Tennessee, 38119-5214, United States
Pfizer Investigational Site
Houston, Texas, 77065, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84109, United States
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2011
First Posted
May 30, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
February 6, 2013
Record last verified: 2013-02