Full Text View
Tabular View
No Study Results Posted
Related Studies
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor.
This study is currently recruiting participants.
Study NCT00404768   Information provided by GlaxoSmithKline
First Received: November 27, 2006   Last Updated: November 19, 2009   History of Changes

November 27, 2006
November 19, 2009
December 2007
May 2010   (final data collection date for primary outcome measure)
Maternal safety and tolerability will be assessed by ECGs, blood pressure, heart rate, fetal ultrasound and blood tests, over 24 hours. The progression of contractions and the fetal heart rate will be continuously monitored, over 48 hours [ Time Frame: Throughout course of study ] [ Designated as safety issue: No ]
  • Maternal safety and tolerability will be assessed by ECGs, blood pressure, heart rate, fetal ultrasound and blood tests, over 24 hours.
  • The progression of contractions and the fetal heart rate will be continuously monitored, over 24 hours
Complete list of historical versions of study NCT00404768 on ClinicalTrials.gov Archive Site
Neonatal Apgar Scores (at birth) and weight gain, head circumference, length and development measured at 6-10 weeks of age (benchmarked to establish norms)Pharmacokinetic parameters [ Time Frame: Throughout course of study ] [ Designated as safety issue: No ]
  • Neonatal Apgar Scores (at birth) and weight gain, head circumference, length and development measured at 4 - 6 weeks of age (benchmarked to establish norms)
  • Pharmacokinetic parameters
 
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor.
See Detailed Description

Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149A is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, patients with preterm labor will be given an intravenous infusion of GSK221149A over approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study, patients with preterm labor will be give an intravenous infusion of GSK221149A over approximately 48 hours. The use of a rescue tocolytic is allowed in the study.

A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously and to investigate the pharmacokinetics of GSK221149A administered orally to healthy, pregnant females with uncomplicated pre-term labor between 300/7 and 356/7 weeks' gestation

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study
Premature Labor
  • Drug: Placebo
  • Drug: GSK221149A
  • Placebo Comparator: Placebo
  • Experimental: GSK221149A
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
75
 
May 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Healthy pregnant females, 30 -36 weeks pregnant, without ruptured membranes
  • 18-45 inclusive
  • Symptoms of pre-term labor, (greater than or equal to 6 uterine contractions per hour, each of which at least 30 sec in duration, with cervical dilatation of less than or equal to 4 cm, (measured by tocodynamometry).

Exclusion criteria:

  • 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
  • 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)
Female
18 Years to 45 Years
No
Contact: US GSK Clinical Trials Call Center 877-379-3718
United States,   Argentina,   Bulgaria,   France,   Korea, Republic of,   Lithuania,   Puerto Rico,   Singapore,   Spain,   United Kingdom
 
NCT00404768
Study Director, GSK
OTA105256
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP