A Phase III study where the treatment groups are assigned by chance and neither the patient or the study doctor know which treatment the patient will receive that will take place in many sites and will compare the efficacy of Retosiban with placebo in stopping spontaneous preterm labor and prolonging labor

Phase 1

• Conditions: Preterm Labour; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]; MedDRA version: 19.1 Level: PT Classification code 10036600 Term: Premature labour System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

• Registration Number: EUCTR2014-003326-41-GB
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-10
• Study Completion: 2017-07-24
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

subject will be eligible for inclusion in this study only if all of the following criteria apply:
1. Signed and dated written informed consent is required prior to a subject’s participation in the study 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 Labour (NOTE: Since local laws, customs, and institutional practice vary globally, investigator discretion in the enrollment of pediatric subjects is permitted, expect in Italy)
Italian Subjects: In Italy, the age restriction for study enrollment is 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 the earliest ultrasound performed before 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 criteria (a and 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

b. 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) consistent 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.
OR
-A 1-cm increase in cervical dilation by digital cervical examination

5. Current or past tocolytic treatment as follows:
a. Subje

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria
apply:
1. Fever with a temperature >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 or 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. Current active liver or biliary disease (with the exception of Gilbert’s syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment)
NOTES:
Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis
Chronic stable hepatitis B and C (e.g., presence of hepatitis B surface antigen (or positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study treatment) are acceptable if subject otherwise meets entry criteria
11. History of sensitivity to any of the IPs or components thereof or a history of drug or other allergy that, in the opinion of the investigator or PPD medical monitor, contraindicates the subject’s participation

Study & Design

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