EUCTR2014-000499-24-SE
Active, not recruiting
Phase 1
Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies - Follow-Up Study to Assess Long-Term Safety of Infants and Children exposed to Retosiban
Conditionspreterm labour and improve neonatal healthMedDRA version: 20.1Level: PTClassification code 10036595Term: Premature deliverySystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Not possible to specify
DrugsTractocile
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- preterm labour and improve neonatal health
- Sponsor
- GlaxoSmithKline Research & Development Limited
- Enrollment
- 330
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants eligible for enrollment in the study must meet all of the following criteria:
- •1\.Mother is randomly assigned and dosed (retosiban or comparator) in 1 of the Phase III retosiban clinical studies.
- •2\.Infant is alive at 28 days post EDD.
- •3\.Written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. The parent/legal guardian of participants aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 330
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •All infants who meet the inclusion criteria will be eligible to enroll in the study. There are no formal exclusion criteria for participation.
Outcomes
Primary Outcomes
Not specified
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