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NCT02292784 · ClinicalTrials.gov registry record · Phase 3
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
NCT02292784 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 98 participants.
The verdict
NCT02292784, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG Retosiban
- DRUG Atosiban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2015-06-01 |
| Est. Completion | 2019-09-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02292784
The ClinicalTrials.gov registry entry for NCT02292784 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02292784 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02292784 about?
NCT02292784 is a clinical study titled "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 ou...
What is the current status of trial NCT02292784?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2015-06-01. Estimated completion is 2019-09-02.
What interventions are being tested in trial NCT02292784?
The interventions under investigation include: Placebo (DRUG), Retosiban (DRUG), Atosiban (DRUG).
Who is sponsoring clinical trial NCT02292784?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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