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

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00209326

Purpose

• 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

Condition	Intervention	Phase
Labor, Premature Premature Birth	Drug: FE200440	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety Study
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 (0.3, 1, 3, 10 mg) and Placebo on Stopping Preterm Labour and Uterine Contractions in Pregnant Women With Advanced Gestational Age

Further study details as provided by Ferring Pharmaceuticals:

Estimated Enrollment:	175
Study Start Date:	November 2003
Estimated Study Completion Date:	June 2006

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female

Criteria

Inclusion Criteria:

Signed Informed Consent Form, prior to screening evaluations
Mother and fetus in good general health
Pregnant women age ≥ 18 years
Gestational age (verified by early ultrasound or if an ultrasound is not available by Last Menstrual Period) between 34 weeks + 0 days and 35 weeks + 6 days (both days inclusive)
At randomisation, there must be 6 or more uterine contractions of at least 30 seconds duration during a 30 minutes interval
At randomisation, the cervical length must be ≤ 15 mm (by transvaginal ultrasound)
At randomisation, the cervical dilatation must be >1 cm and <4 cm (by vaginal examination

Exclusion Criteria:

Contraindications for the mother or the fetus to stop labour, including
- clinical suspicion of abruptio placenta
- known or suspected infection (e.g. urinary tract infection, chorioamnionitis)
Controlled or uncontrolled diabetes mellitus (pre-gestational or gestational)
Eclampsia or severe preeclampsia in the current pregnancy
Previous major uterine surgery (e.g. myomectomy for leiomyomas), congenital uterine abnormalities, large leiomyomas, or retained intrauterine device
Rupture of membrane in the current pregnancy
Placenta praevia in the current pregnancy
a)
Oligohydramnios or polyhydramnios in the current pregnancy defined as amniotic fluid index (AFI) below 7.2 cm or above 27.8 cm
Fetal weight (based on ultrasound) outside the ± 2SD limits provided in Appendix B
Use of cervical cerclage in the current pregnancy
Current multiple pregnancy
Fetal death in utero in previous or current pregnancy
Fetus with known or suspected abnormal karyotype or major malformations in the current pregnancy
Abnormal fetal heart rate which the Investigator judges to reflect fetal distress
Treatment with nifedipine, non-steroidal anti-inflammatory agents (NSAIDs) or intravenously administered magnesium sulphate for contractions during the current pregnancy or treatment with beta-mimetics, atosiban or progesterone within the last 7 days prior to randomisation
Treatment with anticoagulation or fibrinolytic therapies prior to screening, or known or suspected or past history of thromboembolic disorders
Known, suspected or past history of hypocoagulability or coagulation deficiency conditions
Known or suspected hemoglobinopathies
Use of any investigational drug during the current pregnancy
Known, suspected or past history (last 12 months) of alcohol or drug abuse
Known hypersensitivity to the active ingredient or to any of its excipients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209326

Show 17 Study Locations

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Chair:	Morten Hedegaard, MD	Obstetrics Department, Rigshospitalet
Study Director:	Joan-Carles Arce, MD	Obstetrics & Gynecology, Clinical Research & Development, Ferring

More Information

Study ID Numbers:	FE200440, CS004
Study First Received:	September 12, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00209326
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

ClinicalTrials.gov processed this record on January 16, 2009