The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor. - Full Text View

Sponsor:	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 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.

Condition	Intervention	Phase
Premature Labor	Drug: Placebo Drug: GSK221149A	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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 48 hours [ Time Frame: Throughout course of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	75
Study Start Date:	December 2007
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Placebo	Drug: Placebo Matched Placebo to Drug
Treatment: Experimental GSK221149A	Drug: GSK221149A 6mg/h and 12 mg/h

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 300/7 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, 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)

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 48 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OTA105256
Study First Received:	November 27, 2006
Last Updated:	March 4, 2010
ClinicalTrials.gov Identifier:	NCT00404768 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Pre Term Labor
intravenous
fetal fibronectin

Additional relevant MeSH terms:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications

ClinicalTrials.gov processed this record on March 18, 2010