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

Completed

• Conditions: Infant Developmental Assessment
• Interventions: Other: Unintentional exposure in utero

• Registration Number: NCT01362660
• Lead Sponsor: Pfizer

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-05-26
• Study First Posted: 2011-05-30
• Study Start: 2011-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-05
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants with potential exposure in utero	Unintentional exposure in utero	-

Primary Outcome Measures

Name	Time	Method
Bayley Infant Neurodevelopmental Screener	15 months
Receptive-Expressive Emergent Language Test	15 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Salt Lake City, Utah, United States