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

Last updated on November 14, 2019

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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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Descriptive Information
Brief TitleA Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth
Official TitleA 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
Brief SummaryThis 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).
Detailed DescriptionThis 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.
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationInfants with potential exposure in utero through their parents partcipation in a tanezumab clinical study
ConditionInfant Developmental Assessment
InterventionOther: 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).
Study Groups/CohortsInfants with potential exposure in utero
Intervention: Other: Unintentional exposure in utero
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: February 5, 2013)
7
Original Estimated Enrollment
 (submitted: May 26, 2011)
10
Actual Study Completion DateJune 2012
Actual Primary Completion DateJune 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study:All
Agesup to 15 Months   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01362660
Other Study ID NumbersA4091055
NEONATAL MONITORING
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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