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Clinical Trials/EUCTR2014-001826-13-DE
EUCTR2014-001826-13-DE
Active, not recruiting
Phase 1

Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor - Study comparing the Efficacy and Safety of Retosiban Versus Atosiban in Spontaneous Preterm labor

GlaxoSmithKline Research & Development Limited0 sites330 target enrollmentDecember 19, 2014
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Conditionspreterm laborMedDRA version: 19.1Level: PTClassification code 10036595Term: Premature deliverySystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsTractocile

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
preterm labor
Sponsor
GlaxoSmithKline Research & Development Limited
Enrollment
330
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 19, 2014
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

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 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

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
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 laborpreterm laborMedDRA version: 17.1Level: PTClassification code 10036595Term: Premature deliverySystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
EUCTR2014-001826-13-ESGlaxoSmithKline Research & Development Limited330
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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 laborpreterm laborMedDRA version: 19.1Level: PTClassification code 10036595Term: Premature deliverySystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
EUCTR2014-001826-13-SEGlaxoSmithKline Research & Development Limited330
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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 laborpreterm laborMedDRA version: 18.0 Level: PT Classification code 10036595 Term: Premature delivery System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
EUCTR2014-001826-13-GBGlaxoSmithKline Research & Development Limited97
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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 laborpreterm laborMedDRA version: 19.1Level: PTClassification code 10036595Term: Premature deliverySystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
EUCTR2014-001826-13-BEGlaxoSmithKline Research & Development Limited330
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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 laborpreterm laborMedDRA version: 18.0Level: PTClassification code 10073024Term: Preterm premature rupture of membranesSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
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