Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
Completed · Phase 3 · Has a placebo group
Conditions studied: Osteoarthritis, Cancer Pain, Recurrent Low Back Pain
In brief
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.
Key facts
- Study ID
- NCT03031938
- Run by
- Pfizer
- People needed
- 4
- Starts
- 2017-11-03
- Expected to finish
- 2020-06-04
- Last updated by the study team
- 2021-06-25
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- There are no exclusion criteria for participating in this study.
Where it is running
- USC Keck School of Medicine — Los Angeles, California, United States
- Gulfcoast Research Institute — Sarasota, Florida, United States
- Kennedy and White Orthopaedic Center — Sarasota, Florida, United States
- Pediatric Epilepsy & Neurology Specialists — Tampa, Florida, United States
- Lafayette Clinical Research Group — Lafayette, Indiana, United States
- Preferred Pediatrics — Lafayette, Indiana, United States
Full record on ClinicalTrials.gov
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