The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (34-36 Weeks), In Pre-Term Labor.

This study is currently recruiting participants.

Verified by GlaxoSmithKline, June 2009

First Received: November 27, 2006 Last Updated: June 25, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00404768

Purpose

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.

Condition	Intervention	Phase
Premature Labor	Drug: GSK221149A	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	75
Study Start Date:	December 2007
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Detailed Description:

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 340/7 and 356/7 weeks' gestation

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Healthy pregnant females, 34 -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 3 cm, (measured by tocodynamometry).
Positive fetal fibronectin test and/or a cervical length measurement of less than or equal to 20mm.

Exclusion criteria:

single, uncomplicated pregnancy
healthy fetus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404768

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 29 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OTA105256
Study First Received:	November 27, 2006
Last Updated:	June 25, 2009
ClinicalTrials.gov Identifier:	NCT00404768 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Pre Term Labor
intravenous
fetal fibronectin

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications

Additional relevant MeSH terms:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications

ClinicalTrials.gov processed this record on July 02, 2009