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A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Tempe, Arizona, 85282 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Infant Developmental Assessment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-15
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

There are no exclusion criteria for this study

NCT01362660
Pfizer
Completed
A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth

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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
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.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Infants with potential exposure in utero through their parents partcipation in a tanezumab clinical study
Infant Developmental Assessment
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).
Infants with potential exposure in utero
Intervention: Other: Unintentional exposure in utero
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
June 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Sexes Eligible for Study: All
up to 15 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01362660
A4091055
NEONATAL MONITORING
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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