Clinical trial NCT00209326: A Proof of Concept Study Assessing the Effect of Four Different Single Bolus Intravenous Doses of FE200440 and Placebo on Stopping Preterm Labor
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Labor, Premature
Premature Birth
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 163
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: ULB Erasme Hospital Gynecology, Route de Lennik 808
city: Liege
country: Belgium
facility: CHR Citadelle, Boulevard du 12iede Ligne 1
city: Tienen
country: Belgium
facility: AZ Heilig Hart Gynecology, Kliniekstraat 44
city: Brno
country: Czech Republic
facility: Gynekologicko-porodnicka klinika Fakultni nemocnice Brno, Obilni trh 11
city: Jihlava
country: Czech Republic
facility: Gynekologicko-porodnicke oddeleni nemocnice Jihlava, Vrchlickeho 59
city: Plzen
country: Czech Republic
facility: Gynekologicka-porodnicka klinika Fakultni nemocnice, Capkovo namesti 1
city: Praha 2
country: Czech Republic
facility: Gynekologicko-porodnicka klinika 1. LF UK a VFN v Praze, Apolinarska 18
city: Praha 5
country: Czech Republic
facility: Gynekologicko-porodnicka klinika Fakultni nemocnice Motol, V uvalu 84
city: Usti nad Labem
country: Czech Republic
facility: Gynekologicko.porodnicke oddeleni, Socialni pece 12A
city: Kuopio
country: Finland
facility: Kuopio University Hopital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital, Kiinamyllynkatu 4-6
city: Kaunas
country: Lithuania
facility: Kaunas Medical University Clinics, Eiveniu 2
city: Vilnius
country: Lithuania
facility: Vilnius University, Antakalnio 57
city: Bialystok
country: Poland
facility: Zaklad Patofizjologii Ciazy AM w Bialymstoku, M.C. Sklodowskiej 24a
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Urgenta "Elias", Nr. 17, Str. Marasti, sector 1
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean Cluj-Napoca Ginecologie No. 1, Clinica Nr. 1 Ginecologie Nr. 3-5, Str. Clinicilor
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: