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

NCT01362660

Last updated date
Study Location
Pfizer Investigational Site
Tempe, Arizona, 85282, United States
Contact
1-800-718-1021

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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

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Infant Developmental AssessmentA Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth
NCT01362660
  1. Tempe, Arizona
  2. Tempe, Arizona
  3. Wildomar, California
  4. Cutler Bay, Florida
  5. Duncansville, Pennsylvania
  6. Memphis, Tennessee
  7. Houston, Texas
  8. Salt Lake City, Utah
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth
Official Title 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
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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infants with potential exposure in utero through their parents partcipation in a tanezumab clinical study
Condition Infant Developmental Assessment
Intervention 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).
Study Groups/Cohorts Infants 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 Status Completed
Actual Enrollment
 (submitted: February 5, 2013)
7
Original Estimated Enrollment
 (submitted: May 26, 2011)
10
Actual Study Completion Date June 2012
Actual Primary Completion Date June 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
Ages up to 15 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01362660
Other Study ID Numbers A4091055
NEONATAL MONITORING
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2013