drugset / Trial / NCT03031938
Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
NaSingle-groupOpen-labelOther
Summary
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.
Timeline
- Start
- 2017-11-03
- Primary completion
- 2020-06-04
- Completion
- 2020-06-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Celecoxib | Other / unclassified | — | — |
| Background | Diclofenac | Other / unclassified | — | — |
| Background | Naproxen | Small molecule | — | — |
| Background | Tanezumab | Monoclonal antibody | — | — |