|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
| Estimated Enrollment: | 75 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
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 |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Show 29 Study Locations| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| 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 |
|
Pre Term Labor intravenous fetal fibronectin |
|
Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications |
|
Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications |