NCT00209326

A Proof of Concept Study Assessing the Effect of Four Different Single Bolus Intravenous Doses of FE200440 and Placebo on Stopping Preterm Labor

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 (0.3, 1, 3, 10 mg) and Placebo on Stopping Preterm Labour and Uterine Contractions in Pregnant Women With Advanced Gestational Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

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

Conditions

• Labor, Premature
• Premature Birth

Interventions

Type	Name	Description
DRUG	FE200440

Timeline

• Start date: 2003-11-01
• Primary completion: 2006-07-01
• Completion: 2006-08-01
• First posted: 2005-09-21
• Last updated: 2011-12-16

Locations

17 sites across 6 countries: Belgium, Czechia, Finland, Lithuania, Poland, Romania