Labor, PrematurePhase 2NCT00209326
A Proof of Concept Study Assessing the Effect of Four Different Single Bolus Intravenous Doses of FE200440 and Placebo on Stopping Preterm Labor
A Phase 2 study testing FE200440 in people with Labor, Premature and Premature Birth, run by Ferring Pharmaceuticals at 17 sites in 6 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor, Premature, Premature Birth
- What is being tested?
- FE200440
- How many people
- 163 participants
- Where
- 17 sitesin 6 countries
- Study dates
- Nov 2003to Aug 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
Czechia6 sites
Gynekologicko-porodnicka klinika Fakultni nemocnice Brno, Obilni trh 11
Brno, CZ-625 00
Gynekologicko-porodnicke oddeleni nemocnice Jihlava, Vrchlickeho 59
Jihlava, CZ-58 501
Gynekologicka-porodnicka klinika Fakultni nemocnice, Capkovo namesti 1
Pilsen, CZ-307 08
Gynekologicko-porodnicka klinika 1. LF UK a VFN v Praze, Apolinarska 18
Prague, CZ-128 51
Gynekologicko-porodnicka klinika Fakultni nemocnice Motol, V uvalu 84
Prague, CZ-15006
Gynekologicko.porodnicke oddeleni, Socialni pece 12A
Ústí nad Labem, CZ-400 01
Belgium3 sites
ULB Erasme Hospital Gynecology, Route de Lennik 808
Brussels, BE-1070
CHR Citadelle, Boulevard du 12iede Ligne 1
Liège, BE-4000
AZ Heilig Hart Gynecology, Kliniekstraat 44
Tienen, BE-3299
Finland3 sites
Kuopio University Hopital
Kuopio, FI-70210
Tampere University Hospital
Tampere, FI-33521
Turku University Hospital, Kiinamyllynkatu 4-6
Turku, FIN-20521
Lithuania2 sites
Kaunas Medical University Clinics, Eiveniu 2
Kaunas, LT-50009
Vilnius University, Antakalnio 57
Vilnius, LT-10207
Romania2 sites
Spitalul Clinic de Urgenta "Elias", Nr. 17, Str. Marasti, sector 1
Bucharest, RO-011461
Spitalul Clinic Judetean Cluj-Napoca Ginecologie No. 1, Clinica Nr. 1 Ginecologie Nr. 3-5, Str. Clinicilor
Cluj-Napoca, RO-3400
Poland1 site
Zaklad Patofizjologii Ciazy AM w Bialymstoku, M.C. Sklodowskiej 24a
Bialystok, PO - 15-276
About this 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
- 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
Read the 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
- Conditions
- Labor, Premature, Premature Birth
- Being tested
- FE200440
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FE200440Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionJul 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209326
- Sponsor's protocol ID
- FE200440 CS004
- Status last verified
- Dec 2011
- First submitted
- 12 Sep 2005
- Last updated
- 16 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00209326
- Acronym / sponsor ID
- FE200440 CS004
- Conditions
- Labor, Premature, Premature Birth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (23 listed)
- Contraindications for the mother or the fetus to stop labour, including
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FE200440 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FE200440 in people with Labor, Premature and Premature Birth, run by Ferring Pharmaceuticals at 17 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Czechia, Belgium, Finland, Lithuania, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2011.