Uncomplicated preterm labour MedDRA version: 8.1 Level: LLT Classification code 10023555 Term: Labour premature
Conditions
Interventions
Product Name: GSK221149A
Product Code: GSK221149A
Pharmaceutical Form: Tablet
CAS Number: 820957-38-8
Current Sponsor code: GSK221149A
Sponsors
GlaxoSmithKline Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part A and Part B 1. At least 18 years of age 2. 340/7 -356/7 weeks (best obstetric estimate, preferably first trimester ultrasound) with singleton pregnancy 3. Symptoms of pre-term labor: =6 uterine contractions per hour, each of at least 30 sec in duration as measured by tocodynamometry, with cervical dilatation =3cm 4. Intact fetal membranes Part C 1. At least 18 years of age 2. 300/7 -356/7 weeks (best obstetric estimate, preferably first trimester ultrasound) with singleton pregnancy 3. Symptoms of pre-term 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 =2 cm or a definitive cervical change from baseline assessment. 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 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. Any clinically relevant pre-existing or pregnancy-related co-morbid condition that may affect maternal pregnancy outcome or neonatal outcome (eg. hypertension, diabetes mellitus, bleeding/clotting diathesis) 3. Known fetal intrauterine growth restriction or fetal congenital anomaly 4. 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.) 13. QTc > 480 msec for patients with Bundle Branch Block 14. Use of illicit drugs or positive urine drug screen during pregnancy 15. Any tocolytic therapy within 24 hours 16. Any contraindication to tocolytic therapy, including (but not limited to) suspected intrauterine infection, vaginal bleeding, pre-eclampsia/eclampsia 17. Trauma within 48 hours of presentation in preterm labor 18. Subjects treated with dexamethasone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Parts A and B 1. To describe the maternal safety and tolerability of GSK221149A administered intravenously to healthy pregnant women in PTL between 340/7 and 356/7 weeks gestation 2. To describe the fetal safety and tolerability of GSK221149A administered intravenously to healthy pregnant women in PTL between 340/7 and 356/7 weeks gestation 3. To evaluate the pharmacodynamics of GSK221149A in pregnant women in pre-term labor between 340/7 and 356/7 weeks gestation 4. To characterize the pharmacokinetics of GSK221149A administered intravenously to pregnant females in pre-term labor between 340/7 and 356/7 weeks gestation Part C Same objectives as above but administered intravenously to pregnant females in pre-term labor between 30 0/7 and 35 6/7 weeks gestation ; Secondary Objective: Parts A and B 1. To describe the effect of maternal treatment with GSK221149A on short term neonatal growth and development 2. To characterize the pharmacokinetics of GSK221149A administered orally to pregnant females in pre-term labor between 34 0/7 and 35 6/7 weeks gestation as data permit Part C 1. To describe the effect of maternal treatment with GSK221149A on short term neonatal growth and well-being ; Primary end point(s): Parts A and B: 1. Maternal safety and tolerability, (vital signs, ECGs, clinical laboratory tests, adverse events) during acute therapy and for approximately 24 hours after the initiation of therapy compared to placebo and baseline 2. Assessment of fetal heart rate before, during and after therapy and amniotic fluid index (AFI) measurements before, during and after therapy with | — |
Countries
Bulgaria, France, Lithuania, Spain, United Kingdom
Outcome results
None listed