Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-26
Brief Title:
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ Daridorexant
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
Healthcare Claims Database Study to Provide Safety Information on Maternal Fetal and Infant Outcomes Among Women Exposed to QUVIVIQ Daridorexant During Pregnancy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Healthcare claims database study to provide safety information on maternal fetal and infant outcomes among women exposed to QUVIVIQ daridorexant during pregnancy
Detailed Description:
This is a longitudinal observational cohort study using an electronic database of healthcare claims data Safety information will be retrospectively collected from the database and pre-specified diagnostic codes will be used to identify pregnancy and infant outcomes The study will include two phases a patient accrual phase Phase 1 and an analysis phase Phase 2
Descriptive statistics will be conducted to characterize the patient population and to support the interpretation of comparative analyses Comparative analyses will be performed to estimate the effect of QUVIVIQ exposure during pregnancy on the study outcomes Approximately 419 mother-infant pairs with exposure to QUVIVIQ and 1676 mother-infant pairs with exposure to non-orexin receptor antagonist insomnia medication are expected with a 14 ratio of exposedactive comparator patients
Analysis of the prevalence of each specific pregnancy or infant outcome will comprise 1 a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy QUVIVIQ-exposed group and women with insomnia exposed to any non-orexin receptor antagonist insomnia medication during or shortly prior to pregnancy active comparator group 2 a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy QUVIVIQ-exposed group and women with insomnia unexposed to any insomnia medication during or shortly prior to pregnancy unexposed comparator group
Descriptive statistics will be conducted to characterize the patient population and to support the interpretation of comparative analyses Comparative analyses will be performed to estimate the effect of QUVIVIQ exposure during pregnancy on the study outcomes Approximately 419 mother-infant pairs with exposure to QUVIVIQ and 1676 mother-infant pairs with exposure to non-orexin receptor antagonist insomnia medication are expected with a 14 ratio of exposedactive comparator patients
Analysis of the prevalence of each specific pregnancy or infant outcome will comprise 1 a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy QUVIVIQ-exposed group and women with insomnia exposed to any non-orexin receptor antagonist insomnia medication during or shortly prior to pregnancy active comparator group 2 a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy QUVIVIQ-exposed group and women with insomnia unexposed to any insomnia medication during or shortly prior to pregnancy unexposed comparator group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None