Preterm labour MedDRA version: 9.1 Level: LLT Classification code 10023555 Term: Labour premature
Conditions
Interventions
Product Name: GSK221149A
Product Code: GSK221149A
Pharmaceutical Form: Solution for infusion
CAS Number: 820957-38-8
Current Sponsor code: GSK221149A
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
GlaxoSmithKline Research and Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 to 45 years of age inclusive 2. 30 0/7 -35 6/7 weeks (best obstetric estimate, preferably first trimester ultrasound) with singleton pregnancy 3. Symptoms of preterm labor: contractions at a frequency of = 4 per 30 min or = 6 per hour, each of at least 30 sec in duration and confirmed by tocodynamometry 4. Cervical dilatation =1 to =4 cm. Subjects can not exceed a maximum cervical dilation of 4 cm to be included in this study at the time of screening 5. Intact fetal membranes 6. Ability to understand and provide written informed consent to participate in this study 7. Women with gestational diabetes diagnosed during current pregnancy and controlled by diet and exercise will be permitted into this study. Women must have a nonfasting glucose level at screening between 70 mg/dL = 130 mg/dL by point-of-care glucometer or between 70 mg/dL = 140 mg/dL by local laboratory determination to be enrolled in the study 8. Women previously administered tocolytic treatment, which has been discontinued by the investigator for lack of efficacy or intolerance, do not require a 24-hour washout period if otherwise eligible for the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any clinically relevant abnormality identified on the screening examination or any other medical condition or circumstance making the patient (mother and/or fetus) unsuitable for participation in the study 2. Patients who have received a cervical cerclage currently or in a previous pregnancy 3. Any clinically relevant preexisting or pregnancy-related co-morbid condition that may affect maternal pregnancy outcome or neonatal outcome (eg. hypertension, diabetes mellitus, bleeding/clotting diathesis) 4. Patients who have received a third trimester amniocentesis. Patients who have received a first and second trimester amniocentesis are allowed in the study if the results are normal 5. Women with gestational diabetes requiring insulin or pre-existing diabetes mellitus are excluded from this study. Use of oral antidiabetic agents for gestational diabetes is also exclusionary 6. Known fetal intrauterine growth restriction or fetal congenital anomaly 7. Abnormal modified biophysical profile (NST is non-reactive and AFI 450 msec (either QTcb or QTcf, machine or manual overread, on single or average QTc value of triplicate ECGs obtained over a brief recording period.) 16. QTc > 480 msec for patients with Bundle Branch Block 17. Use of illicit drugs or positive urine drug screen any time during pregnancy 18. Any contraindication to tocolytic therapy, including (but not limited to) suspected intrauterine infection, vaginal bleeding (including ante-partum hemorraghe), pre-eclampsia/eclampsia, placenta previa, removal of placenta, and intrauterine fetal death. 19. Trauma within 48 hours of presentation in preterm labor 20. Subjects previously enrolled in Study OTA105256 21. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To describe the effect of maternal treatment with GSK221149A on short term neonatal growth and well-being;Main Objective: 1. To describe the maternal safety and tolerability of GSK221149A administered intravenously to healthy pregnant women in PTL between 30 0/7 and 35 6/7 weeks gestation 2. To describe the fetal safety and tolerability of GSK221149A administered intravenously to healthy pregnant women in PTL between 30 0/7 and 35 6/7 weeks gestation 3. To evaluate the pharmacodynamics of GSK221149A in pregnant women in preterm labor between 30 0/7 and 35 6/7 weeks gestation 4. To characterize the pharmacokinetics of GSK221149A administered intravenously to pregnant females in preterm labor between 300/7 and 356/7 weeks gestation ;Primary end point(s): 1. Maternal safety and tolerability, (vital signs, ECGs, clinical laboratory tests, adverse events) during acute therapy and for approximately 48 hours after the initiation of therapy compared to placebo and baseline 2. Assessment of fetal heart rate and amniotic fluid index (AFI) measurements before, during, and after treatment with GSK221149A compared to placebo and baseline 3. Proportion of patients who achieve >= 50% reduction in number of contractions [contractions defined in part by lasting at least 30 seconds, abbreviated as: >30 secs] per hour from baseline together with no cervical dilation increase within the first 6 hours of therapy | — |
Countries
United Kingdom
Outcome results
None listed