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; MedDRA version: 20.1Level: PTClassification code 10036600Term: Premature labourSystem 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: EUCTR2014-003326-41-IT
• Lead Sponsor: GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-28
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 900

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.
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 18 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes in preterm (NOTE: Since local laws, customs, and institutional practice vary globally, investigator discretion in the enrollment of pediatric subjects is permitted)
3. Gestational age between 240/7 and 336/7 weeks as determined by (1) known fertilization date, either in vitro fertilization or intrauterine insemination, (2) last menstrual period confirmed by the earliest ultrasound prior to 240/7 weeks gestation,
or (3) the earliest ultrasound alone prior to 240/7 weeks gestation, whichever is the most accurate method available for each subject. In situations where prenatal ultrasound records are not available at the time the subject presents, the investigator will make every effort to obtain these records (either via computer records, directly from the subject’s primary care obstetrician, or via telephone). However, in cases in which these records are not readily available (e.g., off hours, holiday), it is within the investigator’s discretion to use GA based on a verbal history from the subject with the intent of getting confirmation from the medical records as soon as possible
4. Females must be diagnosed with preterm labor according to both of the following criteria:
a. Regular uterine contractions at a rate of =4 contractions of at least 30 seconds’ duration during a 30-minute interval confirmed by tocodynamometry
AND at least 1 of the following:
b. Cervical dilation =2 cm and =4 cm by digital cervical examination OR
c. If <2 cm dilation by digital cervical examination, a cervical change consisting of an increase of at least 25% effacement or 1-cm dilation
5. Current or past tocolytic treatment as follows:
a. Subjects in whom tocolytic treatment has not been initiated prior to consent are eligible for the study
b. Transferred or referred subjects for whom parenteral magnesium sulfate treatment has been started before Screening are eligible provided they meet all eligibility criteria
c. Subjects receiving a prohibited tocolytic in this study are eligible only if the treatment is stopped before randomization and provided they meet all eligibility criteria
d. Subjects with a historical failure of a tocolytic treatment in a previous episode of preterm labor during the current pregnancy are eligible provided they meet all eligibility criteria
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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) 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), 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 urine drug screen positive for cocaine, phencyclidine (PCP), methamphetamine, or amphetamine
9. Women in whom the combination of history and screening test results is suggestive of abuse or dependency that may have the potential to complicate the pregnancy outcome. NOTE: Exclusion of a subject with a positive findings for substances other than cocaine, PCP, methamphetamine, or amphetamine is at the investigator’s discretion (examples include alcohol, cannabinoids, and opiates)
10. 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
11. 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
12. 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