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Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
USC Keck School of Medicine
Los Angeles, California, 90033 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Cancer Pain, Recurrent Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-2
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.

- The infant's mother (who was the tanezumab clinical study participant) must review,
agree and sign an informed consent document explaining the details of the perinatal
and post natal follow up. Where local regulations mandate, the male parent would also
review and sign the informed consent.

- Parents or legal guardian must be willing and able to comply with scheduled visits and
study procedures.

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

- There are no exclusion criteria for participating in this study.

NCT03031938
Pfizer
Recruiting
Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies

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Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
A Protocol To Monitor From Birth To Age 15 Months The Neurological Development Of Infants With Exposure In-utero In Tanezumab Clinical Studies At All Investigational Sites
A4091065 is a multicenter, prospective, cohort study with enhance physical an neurodevelopmental surveillance to characterize the outcomes related to the development of infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or comparator via maternal exposure or in utero in any tanezumb study.
A4091065 is a long term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Osteoarthritis
  • Cancer Pain
  • Recurrent Low Back Pain
Drug: Investigational medical product (IMP) administered in parent study
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study
Cohort 1
Long term observational study of subjects from tanezumab parent study
Intervention: Drug: Investigational medical product (IMP) administered in parent study
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10
July 2020
January 2020   (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.
  • The infant's mother (who was the tanezumab clinical study participant) must review, agree and sign an informed consent document explaining the details of the perinatal and post natal follow up. Where local regulations mandate, the male parent would also review and sign the informed consent.
  • Parents or legal guardian must be willing and able to comply with scheduled visits and study procedures.

Exclusion Criteria:

  • There are no exclusion criteria for participating in this study.
Sexes Eligible for Study: All
up to 2 Months   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03031938
A4091065
2013-002548-10 ( EudraCT Number )
INFANT SAFETY FOLLOW-UP #2 ( Other Identifier: Alias Study Number )
NEONATAL MONITORING STUDY #2 ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Eli Lilly and Company
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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.

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