An observational study in Infant Developmental Assessment, sponsored by Pfizer. Completed at 8 sites in United States. Open to participants aged Up to 15 Months. Per ClinicalTrials.gov, last updated 2013-02-06.
Sponsored by Pfizer · Observational
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).
This study will enroll infants with potential tanezumab exposure in utero at sites overseen by Schulman and Associates IRB This study will attempt to enroll all infants who qualify.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Infants with potential exposure in utero through their parents partcipation in a tanezumab clinical study
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.
Exclusion Criteria:
There are no exclusion criteria for this study
Other: Unintentional exposure in utero
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).
Bayley Infant Neurodevelopmental Screener
Time frame: 0-2 Months
Bayley Infant Neurodevelopmental Screener
Time frame: 8 months
Bayley Infant Neurodevelopmental Screener
Time frame: 15 months
Receptive-Expressive Emergent Language Test
Time frame: 0-2 Months
Receptive-Expressive Emergent Language Test
Time frame: 8 months
Receptive-Expressive Emergent Language Test
Time frame: 15 months
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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