Obstetric Labour, Premature Clinical Trial
Official title:
Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) treatment studies, to provide assurance that treatment is not associated with significant adverse outcomes in early childhood. The enrolled infants and children will be followed at pre-specified intervals until they reach 24 months chronological age. This study does not require medical interventions or study visits to an investigational site, instead, parents or legal guardians will be prompted at certain time points to complete developmental questionnaires and other data on their children's health status via an electronic device. Data collected during the infant and child follow up study will be managed by a centralized research coordinating center (RCC). Regionally based pediatricians will serve as study principal investigators (referred to as RCC-PIs) for this study. All communications the RCC-PI has with the parent/legal guardian or the child's health care provider (HCP) will occur remotely; there will be no clinic visits.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01702376 -
This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers.
|
Phase 1 | |
| Completed |
NCT00549211 -
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
|
Phase 1 | |
| Completed |
NCT00457925 -
Absorption, Distribution, Metabolism And Excretion Study For GSK221149A
|
Phase 1 | |
| Completed |
NCT00404768 -
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
|
Phase 2 | |
| Terminated |
NCT00449709 -
A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT02377414 -
Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women
|
Phase 1 | |
| Terminated |
NCT02292771 -
A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour
|
Phase 3 | |
| Completed |
NCT01867996 -
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ)
|
Phase 1 | |
| Terminated |
NCT02377466 -
A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
|
Phase 3 | |
| Completed |
NCT01627587 -
A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole
|
Phase 1 |