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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00404768
First received: November 27, 2006
Last updated: April 5, 2012
Last verified: April 2012

November 27, 2006
April 5, 2012
December 2007
June 2011   (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
Not Provided
Not Provided
 
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Obstetric Labour, Premature
  • Drug: GSK221149A
    6mg/h and 12 mg/h
    Other Name: GSK221149A
  • Drug: Placebo
    Matched Placebo to Drug
  • Experimental: Treatment
    GSK221149A
    Intervention: Drug: GSK221149A
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
June 2011
June 2011   (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 information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Colombia,   Korea, Republic of,   Puerto Rico,   Singapore,   Spain,   United Kingdom
 
NCT00404768
OTA105256
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2012

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