Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209326
Status:
COMPLETED
Last Update Posted:
2011-12-16
First Post:
2005-09-12
Brief Title:
A Proof of Concept Study Assessing the Effect of Four Different Single Bolus Intravenous Doses of FE200440 and Placebo on Stopping Preterm Labor
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
Study Overview
Official Title:
A Randomised Double-blind Parallel Group Dose-ranging Placebo-controlled Multi-centre Proof of Concept Study Assessing the Effect of Four Different Single Bolus Intravenous Doses of FE200440 03 1 3 10 mg and Placebo on Stopping Preterm Labour and Uterine Contractions in Pregnant Women With Advanced Gestational Age
Status:
COMPLETED
Status Verified Date:
2011-12
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:
To determine the effects of four different single bolus doses of FE200440 administered intravenously on stopping preterm labour compared to placebo in pregnant women with advanced gestational age
Detailed Description:
To determine the effects of four different single bolus doses of FE200440 administered intravenously on stopping preterm labour compared to placebo in pregnant women with advanced gestational age
To establish the effects of four different single bolus doses of FE200440 administered intravenously on uterine contractions compared to placebo
To evaluate the effects of four different single bolus doses of FE200440 administered intravenously on labour progression compared to placebo
To establish the dose-response curve of single bolus doses of FE200440 administered intravenously in terms of time to delivery uterine contractions and labour progression
To determine the duration of action of four different single bolus doses of FE200440 administered intravenously in terms of time to delivery uterine contractions and labour progression
To establish the pharmacokinetic parameters of FE200440 after single bolus intravenous administration
To determine the relation between plasma concentrations of FE200440 and uterine contractions and labour progression
To compare the maternal fetal and infant safety profile after intravenous administration of four different single bolus doses of FE200440 and placebo
To evaluate the impact of four different single bolus doses of FE200440 administered intravenously on delivery outcome postpartum events and lactation
To establish the effects of four different single bolus doses of FE200440 administered intravenously on uterine contractions compared to placebo
To evaluate the effects of four different single bolus doses of FE200440 administered intravenously on labour progression compared to placebo
To establish the dose-response curve of single bolus doses of FE200440 administered intravenously in terms of time to delivery uterine contractions and labour progression
To determine the duration of action of four different single bolus doses of FE200440 administered intravenously in terms of time to delivery uterine contractions and labour progression
To establish the pharmacokinetic parameters of FE200440 after single bolus intravenous administration
To determine the relation between plasma concentrations of FE200440 and uterine contractions and labour progression
To compare the maternal fetal and infant safety profile after intravenous administration of four different single bolus doses of FE200440 and placebo
To evaluate the impact of four different single bolus doses of FE200440 administered intravenously on delivery outcome postpartum events and lactation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None