CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4 enrolled
Drug / intervention
Investigational medical product (IMP) administered in parent studydrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03031938
NCT03031938Phase 3Completed
CompareCT.gov

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

Pfizer·interventional·Posted Jan 26, 2017·Updated Jun 25, 2021

In Brief

A Phase 3 clinical trial evaluating Investigational medical product (IMP) administered in parent study for Osteoarthritis and 2 related conditions. Completed, enrolled 4 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Cancer Pain, Recurrent Low Back Pain
CountriesUnited States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 26, 2017
Enrollment StartNov 3, 2017
Primary CompletionJun 4, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.4 years ago

Interventions

Investigational medical product (IMP) administered in parent studydrug

IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study