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

• 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

Study Overview

• Status: Completed
• Conditions: Premature Birth; Labor, Premature
• Intervention / Treatment: Drug: FE200440

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

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, BE-1070
    • ULB Erasme Hospital Gynecology, Route de Lennik 808
  • Liege, Belgium, BE-4000
    • CHR Citadelle, Boulevard du 12iede Ligne 1
  • Tienen, Belgium, BE-3299
    • AZ Heilig Hart Gynecology, Kliniekstraat 44
• Czech Republic
  • Brno, Czech Republic, CZ-625 00
    • Gynekologicko-porodnicka klinika Fakultni nemocnice Brno, Obilni trh 11
  • Jihlava, Czech Republic, CZ-58 501
    • Gynekologicko-porodnicke oddeleni nemocnice Jihlava, Vrchlickeho 59
  • Plzen, Czech Republic, CZ-307 08
    • Gynekologicka-porodnicka klinika Fakultni nemocnice, Capkovo namesti 1
  • Praha 2, Czech Republic, CZ-128 51
    • Gynekologicko-porodnicka klinika 1. LF UK a VFN v Praze, Apolinarska 18
  • Praha 5, Czech Republic, CZ-15006
    • Gynekologicko-porodnicka klinika Fakultni nemocnice Motol, V uvalu 84
  • Usti nad Labem, Czech Republic, CZ-400 01
    • Gynekologicko.porodnicke oddeleni, Socialni pece 12A
• Finland
  • Kuopio, Finland, FI-70210
    • Kuopio University Hopital
  • Tampere, Finland, FI-33521
    • Tampere University Hospital
  • Turku, Finland, FIN-20521
    • Turku University Hospital, Kiinamyllynkatu 4-6
• Lithuania
  • Kaunas, Lithuania, LT-50009
    • Kaunas Medical University Clinics, Eiveniu 2
  • Vilnius, Lithuania, LT-10207
    • Vilnius University, Antakalnio 57
• Poland
  • Bialystok, Poland, PO - 15-276
    • Zaklad Patofizjologii Ciazy AM w Bialymstoku, M.C. Sklodowskiej 24a
• Romania
  • Bucuresti, Romania, RO-011461
    • Spitalul Clinic de Urgenta "Elias", Nr. 17, Str. Marasti, sector 1
  • Cluj-Napoca, Romania, RO-3400
    • Spitalul Clinic Judetean Cluj-Napoca Ginecologie No. 1, Clinica Nr. 1 Ginecologie Nr. 3-5, Str. Clinicilor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Signed Informed Consent Form, prior to screening evaluations
2. Mother and fetus in good general health
3. Pregnant women age ≥ 18 years
4. 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)
5. At randomisation, there must be 6 or more uterine contractions of at least 30 seconds duration during a 30 minutes interval
6. At randomisation, the cervical length must be ≤ 15 mm (by transvaginal ultrasound)
7. At randomisation, the cervical dilatation must be >1 cm and <4 cm (by vaginal examination

Exclusion Criteria:

1. 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)
2. Controlled or uncontrolled diabetes mellitus (pre-gestational or gestational)
3. Eclampsia or severe preeclampsia in the current pregnancy
4. Previous major uterine surgery (e.g. myomectomy for leiomyomas), congenital uterine abnormalities, large leiomyomas, or retained intrauterine device
5. Rupture of membrane in the current pregnancy
6. Placenta praevia in the current pregnancy
7. a)
8. Oligohydramnios or polyhydramnios in the current pregnancy defined as amniotic fluid index (AFI) below 7.2 cm or above 27.8 cm
9. Fetal weight (based on ultrasound) outside the ± 2SD limits provided in Appendix B
10. Use of cervical cerclage in the current pregnancy
11. Current multiple pregnancy
12. Fetal death in utero in previous or current pregnancy
13. Fetus with known or suspected abnormal karyotype or major malformations in the current pregnancy
14. Abnormal fetal heart rate which the Investigator judges to reflect fetal distress
15. 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
16. Treatment with anticoagulation or fibrinolytic therapies prior to screening, or known or suspected or past history of thromboembolic disorders
17. Known, suspected or past history of hypocoagulability or coagulation deficiency conditions
18. Known or suspected hemoglobinopathies
19. Use of any investigational drug during the current pregnancy
20. Known, suspected or past history (last 12 months) of alcohol or drug abuse
21. Known hypersensitivity to the active ingredient or to any of its excipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): December 16, 2011
• Last Update Submitted That Met QC Criteria: December 15, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: FE200440 CS004