EUCTR2006-005807-32-BG进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously and the pharmacokinetics of GSK221149A administered orally in healthy, pregnant females, with uncomplicated pre-term labor between 30 0/7 – 35 6/7 weeks gestation.
GlaxoSmithKline Research and Development0 个研究点目标入组 90 人开始时间: 2009年7月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Part A and Part B
- •1. At least 18 years of age
- •2. 34 0/7 -35 6/7 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
- •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 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 =1 cm 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 the study. Women must have a non-fasting glucose at screening between 70mg/mL and 130 mg/mL by point-of-care dlucomer or between 70mg/mL and 140mg/mL by local laboratory determination to be enrolled in the study.
- •8. Women previously administered tocolytic treatment, which has been discintinued 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
排除标准
- •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. Patients who have received amniocentesis during the third trimester. Patients who have received a first and second trimester amniocentesis are allowed in the study if the results are normel.
- •4. 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)
- •5. Women with gestational diabetes requiring insulin or pre-existing diabetes mellitus are excluded. Use of oral antidiabetis 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 <5)
- •8. Participation in another interventional (i.e any study involving an investigational
- •product or device) clinical trial during the current pregnancy. Women enrolled in an observational, non-interventional, non-device trial will be permitted into the study.
- •9. Abuse of alcohol, defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units. One unit is equivalent to a half-pint
- •(220mL) of beer or 1 (25mL) measure of spirits, or 1 glass (125mL of wine)
- •10. History of anaphylaxis or anaphylactoid reactions, or severe allergic responses to
- •11. Known to be positive for hepatitis C antibody, hepatitis B surface antigen or HIV on prenatal laboratory results
- •12. Use of prescription drugs that are potent CYP3A4 inhibitors, within 7 days or 5 halflives (whichever is longer) prior to first dose of medication.
- •13. Use of dietary/herbal supplements including (but not limited to) St. John's wort,
- •kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, ginseng,
- •and red yeast rice (2-fold greater than the recommended daily allowance of 1200 mg
- •per day) within 7 days prior to first dose of medication
- •14. Consumption of grapefruit or grapefruit juice within 3 days prior to first dose of
- •15. QTc > 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 during pregnancy
- •18. Any contraindication to tocolytic therapy, including (but not limited to) suspected
- •intrauterine infection, vaginal bleeding, pre-eclampsia/eclampsia
- •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 exception of Gilbert's syndrome or asymptomatic gallstones)
研究者
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