Status:
COMPLETED
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
Lead Sponsor:
GlaxoSmithKline
Conditions:
Obstetric Labour, Premature
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
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...
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 invest...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 12 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2011
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00404768
Start Date
October 12 2007
End Date
July 7 2011
Last Update
January 16 2018
Active Locations (57)
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1
GSK Investigational Site
Mobile, Alabama, United States, 36604
2
GSK Investigational Site
Phoenix, Arizona, United States, 85008
3
GSK Investigational Site
Phoenix, Arizona, United States, 85013
4
GSK Investigational Site
Tucson, Arizona, United States, 85712