The purpose of this study is to compare Retosiban with Atosiban and show that retosiban is more effective in stopping spontaneous preterm labor and prolonges labor

Phase 1

• Conditions: preterm labor; MedDRA version: 19.1Level: PTClassification code 10036595Term: Premature deliverySystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2014-001826-13-BE
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-14
• Last Update Posted: 13 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 330

Inclusion Criteria

1.Signed and dated written informed consent is required prior to a subject’s participation in the study 200721 (ZINN) and the performance of any protocol specific procedures. At sites where enrollment of adolescents is allowed, adolescents aged 12 to 17 years must provide written agreement to participate in the study in accordance with applicable regulatory and country or state requirements. Subjects will also be asked to sign a release for medical records at the time of consenting to allow access to both the maternal and neonatal records including information about delivery and infant care as well as information collected prior to the consent having been signed
Note: Prescreening alone does not necessarily require consent as this activity may be accomplished in the absence of study specific procedures or assessments. In many cases, standard care and standard medical triage will provide sufficient information or evidence as to whether or not the subject is eligible for the study
2.Females aged 12 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes in spontaneous preterm labor (Note: This protocol includes pregnant adolescents, aged 12 to 17 years, as appropriate, unless national or local regulations restrict the age for study enrollment to subjects aged 18 to 45 years).
3.Gestational age between 240/7 and 336/7 weeks as determined by
(1) known fertilization date, either in vitro fertilization or intrauterine
insemination, or (2) a best estimated due date confirmed or established
by by the earliest ultrasound prior to 240/7 weeks' gestation. In
situations where prenatal ultrasound records are not available at the
time the subject presents, the investigator may enroll the subject using
the GA based on a verbal history from the subject with the intent of
getting confirmation from the medical records or from the subject's
primary care obstetrician as soon as possible
4.Females must be diagnosed with preterm labor according to both of
the following (a or b):
a.Regular uterine contractions , confirmed by tocodynamometry, at a
rate of =4 contractions of at least 30 seconds duration during a 30-
minute interval. Where tocodynamometry is not technically feasible,
assessment by manual palpation will be permitted and must be
documented
AND at least 1 of the following:
i.Cervical dilation =2 cm and =4 cm by digital cervical examination OR
ii.If <2 cm dilation by the required initial digital cervical examination, a
cervical change (2 examinations must be documented) consisting with 1
of the following:
• An absolute increase of at least 25% effacement (e.g., a change in
effacement from 50% to 75%) by digital examination or a 10 mm
decrease in cervical length by transvaginal ultrasound
• A 1-cm increase in cervical dilation by digital cervical examination
5.Treatment naïve subjects and subjects not adequately responding to tocolytics other than atosiban (e.g., transfers from other care units) during their current episode of preterm labor may be eligible for the study. Historical failure of a tocolytic treatment in a previous episode of preterm labor is not a required inclusion criterion. Tocolytic failure is defined by progressive cervical changes or continuing uterine contractions

Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 324
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects

Exclusion Criteria

1.Fever with a temperature greater than 100.4°F (38°C) for more than 1 hour or =101°F (38.3°C) in the 24 hours prior to the start of study treatment
2.Women with maternal-fetal conditions that potentially necessitate the need for delivery, such as pre-eclampsia or fetal compromise
3.A fetus with any diagnosis, condition, treatment, or other factor that in the opinion of the investigator has the potential to affect or confound assessments of efficacy or safety (e.g., nonreassuring fetal status, intrauterine growth restriction, major congenital anomaly)
4.Preterm premature rupture of membranes
5.Women with any confirmed or suspected contraindication to prolongation of pregnancy, such as placental abruption, chorioamnionitis, or placenta previa
6.Evidence of polyhydramnios (amniotic fluid index [AFI] >25 cm) or oligohydramnios (AFI <5 cm)
7.Women with co-morbid medical or obstetric conditions that in the
opinion of the investigator have the potential to complicate the
pregnancy course and outcomes, such as uncontrolled hypertension,
uncontrolled diabetes (if known, history of glycosylated hemoglobin
>8% at any time during pregnancy), known or suspected maternal Zika
infection during gestation (see SPM for details), or compromise the
safety of the subject, such as underlying cardiovascular disorder
(specifically ischemic cardiac disease, congenital heart disease,
pulmonary hypertension, valvular heart disease, arrhythmias, and
cardiomyopathy)
8.Women with a history of substance abuse during the pregnancy or dependency that may have the potential to complicate the pregnancy outcome
9.Women with any diagnosis, condition, treatment, or other factor that in the opinion of the investigator has the potential to affect or confound assessments of efficacy or safety
10.Women with documented active hepatitis B or hepatitis C viral infection, unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones)
11.History of sensitivity to the IPs or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK/PPD medical monitor,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified