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

February 5, 2013 updated by: Pfizer

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85282
        • Pfizer Investigational Site
      • Tempe, Arizona, United States, 85283
        • Pfizer Investigational Site
    • California
      • Wildomar, California, United States, 92595
        • Pfizer Investigational Site
    • Florida
      • Cutler Bay, Florida, United States, 33189
        • Pfizer Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119-5214
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77065
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants with potential exposure in utero through their parents partcipation in a tanezumab clinical study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants with potential exposure in utero
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bayley Infant Neurodevelopmental Screener
Time Frame: 0-2 Months
0-2 Months
Bayley Infant Neurodevelopmental Screener
Time Frame: 8 months
8 months
Bayley Infant Neurodevelopmental Screener
Time Frame: 15 months
15 months
Receptive-Expressive Emergent Language Test
Time Frame: 0-2 Months
0-2 Months
Receptive-Expressive Emergent Language Test
Time Frame: 8 months
8 months
Receptive-Expressive Emergent Language Test
Time Frame: 15 months
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

May 26, 2011

First Posted (Estimate)

May 30, 2011

Study Record Updates

Last Update Posted (Estimate)

February 6, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A4091055
  • NEONATAL MONITORING

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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