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Clinical Trial 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


Clinical Trial 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 ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00209326
Study type Interventional
Source Ferring Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date November 2003
Completion date August 2006

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