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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00209326
First received: September 12, 2005
Last updated: December 15, 2011
Last verified: December 2011
  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 2

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

Enrollment: 163
Study Start Date: November 2003
Study Completion Date: August 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00209326     History of Changes
Other Study ID Numbers: FE200440 CS004
Study First Received: September 12, 2005
Last Updated: December 15, 2011
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 23, 2014