Trials / Completed
CompletedNCT03031938
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 0 Years – 2 Months
- Healthy volunteers
- Not accepted
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.
Detailed description
A4091065 is a long term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-11-03
- Primary completion
- 2020-06-04
- Completion
- 2020-06-04
- First posted
- 2017-01-26
- Last updated
- 2021-06-25
- Results posted
- 2021-06-25
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03031938. Inclusion in this directory is not an endorsement.